93 214051 Ivabradine Tablets, 5 mg and 7.5 mg Centaur Pharmaceuticals Private Limited Corlanor (Ivabradine) Tablets, 5 mg and 7.5 mg 12/30/2021 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction 92 211538 Vasopressin Injection, USP, 20 Units/mL Multiple Dose Vials Eagle Pharmaceuticals, Inc. Vasostrict (Vasopressin) Injection, 20 units/mL 12/15/2021 To increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines 91 212514 Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial Sun Pharmaceutical Industries Limited AmBisome (Amphotericin B) Liposome for Injection, 50 mg/vial 12/14/2021 For the empirical therapy for presumed fungal infection in febrile, neutropenic patients; for the treatment of Cryptococcal Meningitis in HIV-infected patients; treatment of patients with Aspergillus species, Candida species and/or Cryptococcus; treatment of visceral leishmaniasis 90 212592 Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials IdentiRx Pharmaceuticals, LLC Timoptic (Timolol Maleate) in Ocudose Ophthalmic Solution, 0.25% and 0.5% 12/13/2021 For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma 89 205742 Glycerol Phenylbutyrate Oral Liquid, 1.1 grams/mL Par Pharmaceutical, Inc. Ravicti (Glycerol Phenylbutyrate) Oral Liquid, 1.1 grams/mL 12/2/2021 For the chronic management of patients 2 years of age and older with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone 88 209450 Lubiprostone Capsules, 8 mcg and 24 mcg Amneal Pharmaceuticals LLC Amitiza (Lubiprostone) Capsules, 8 mcg and 24 mcg 11/30/2021 For the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g.,weekly) opioid dosage escalation 87 215624 Atropine Sulfate Ophthalmic Solution USP, 1% Apotex Inc. Atropine Sulfate Ophthalmic Solution, 1% 11/26/2021 For the treatment of cycloplegia, mydriasis, and for the penalization of the healthy eye in the treatment of amblyopia 86 214864 Betaine Anhydrous for Oral Solution, 180 grams/bottle Novitium Pharma LLC Cystadane (Betaine Anhydrous) For Oral Solution, 180 grams/bottle 11/23/2021 For the treatment of homocystinuria to decrease elevated homocysteine blood concentrations 85 203180 Dasatinib Tablets, 80 mg and 140 mg Apotex Inc. Sprycel (Dasatinib) Tablets, 80 mg and 140 mg 11/23/2021 For the treatment of newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy; pediatric patients 1 year of age and older with Ph+ CML in chronic phase; pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy 84 215037 Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single Dose Vial Zydus Pharmaceuticals (USA) Inc. Arranon (Nelarabine) Injection, 250 mg/50 mL 11/17/2021 For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens 83 212152 Fingolimod Capsules, 0.25 mg Teva Pharmaceuticals USA, Inc. Gilenya (Fingolimod) Capsules, 0.25 mg 11/12/2021 For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older 82 211428 Potassium Chloride (20 mEq) in Lactated Ringer's and 5% Dextrose Injection USP, Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride (20 mEq) in Lactated Ringer's and 5% Dextrose Injection 11/9/2021 For patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories 81 214102 Valsartan Oral Solution, 20 mg/5 mL (4 mg/mL) Novitium Pharma LLC Prexxartan (Valsartan) Oral Solution, 20 mg/5 mL 11/2/2021 For the treatment of hypertension, for the treatment of heart failure and to reduce risk of cardiovascular death in patients following myocardial infarction who are unable to swallow valsartan tablets 80 205775 Everolimus Tablets, 0.25 mg,  0.5 mg, 0.75 mg and 1 mg Par Pharmaceutical, Inc. Zortress (Everolimus) Tablets, 0.25 mg,  0.5 mg, 0.75 mg and 1 mg 10/18/2021 For the prophylaxis of organ rejection in adult patients 79 209348 Lenalidomide Capsules , 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg Dr. Reddy's Laboratories Limited Revlimid (Lenalidomide) Capsules , 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg 10/14/2021 For the treatment for multiple myeloma 78 213729 Carglumic Acid Tablets for Oral Suspension, 200 mg Novitium Pharma LLC Carbaglu (Carglumic Acid) Tablets for Oral Suspension, 200 mg 10/14/2021 For adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency; maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency 77 209708 Mivacurium Chloride Injection, 10 mg/5 mL (2 mg/mL) and 20 mg/10 mL (2 mg/mL) Single-dose Vials (Preservative Free) Woodward Pharma Services, LLC Mivacron (Mivacurium Chloride) Injection, 10 mg/5 mL (2 mg/mL) and 20 mg/10 mL (2 mg/mL) Single-dose Vials 10/12/2021 For inpatients and outpatients, as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation 76 206254 Romidepsin for Injection, 10 mg/vial, Single Dose Vial Fresenius Kabi USA, LLC Istodax (Romidepsin for Injection), 10 mg/vial 10/12/2021 For the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy 75 213584 Oxymetazoline Hydrochloride Cream, 1% Taro Pharmaceuticals Inc. Rhofade (Oxymetazoline Hydrochloride) Cream, 1% 10/4/2021 For the topical treatment of persistent facial erythema associated with rosacea in adults 74 212469 Zolmitriptan Nasal Spray USP, 2.5 mg and 5 mg Padagis Israel Pharmaceuticals Ltd. Zomig (Zolmitriptan) Nasal Spray USP, 2.5 mg and 5 mg 9/30/2021 For the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older 73 209158 Brimonidine Topical Gel, 0.33% Padagis Israel Pharmaceuticals Ltd. Mirvaso (Brimonidine) Topical Gel, 0.33% 9/23/2021 For the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older 72 208075 Ceftaroline Fosamil for Injection, 400 mg and 600 mg Single-Dose Vials Apotex Inc. Teflaro (Ceftaroline Fosamil) for Injection, 400 mg and 600 mg Single-Dose Vials 9/21/2021 For the treatment of acute bacterial skin and skin structure infections in adult and pediatric patients 2 months of age and older; community-acquired bacterial pneumonia in adult and pediatric patients 2 months of age and older 71 211146 Vortioxetine Tablets, 5 mg, 10 mg, and 20 mg Zydus Pharmaceuticals (USA) Inc. Trintellix (Vortioxetine) Tablets, 5 mg, 10 mg, and 20 mg 9/17/2021 Indicated for the treatment of major depressive disorder (MDD) in adults 70 212463 Eliglustat Capsules, 84 mg Aizant Drug Research Solutions Pvt. Ltd. Cerdelga (Eliglustat) Capsules, 84 mg 9/8/2021 For the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers as detected by an FDA-cleared test 69 215003 Paroxetine Oral Suspension, 10 mg (base)/5 mL Novitium Pharma LLC Paxil (Paroxetine) Oral Suspension, 10 mg/5 mL 9/3/2021 For the treatment of Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, and Posttraumatic Stress Disorder 68 208335 Linagliptin Tablets, 5 mg Sunshine Lake Pharma Co., Ltd. Tradjenta (Linagliptin) Tablets, 5 mg 8/31/2021 Adjunct treatement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 67 208336 Linagliptin and Metformin Hydrochloride Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg Sunshine Lake Pharma Co., Ltd. Jentadueto (Linagliptin and Metformin Hydrochloride) Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg 8/30/2021 Adjunct treatement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 66 214264 Tofacitinib Extended-Release Tablets, 11 mg and 22 mg Zydus Pharmaceuticals (USA) Inc Xeljanz XR (Tofacitinib) Extended-Release Tablets, 11 mg and 22 mg 8/19/2021 For the treatment of adult patients with moderately to severely active rheumatoid arthritis; active psoriatic arthritis;  moderately to severely active ulcerative colitis 65 213914 Sunitinib Malate Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg Sun Pharmaceutical Industries Limited Sutent (Sunitinib Malate) Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg 8/16/2021 For the treatment of adult patients with gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate; treatment of adult patients with advanced renal cell carcinoma (RCC); adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy; treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in adult patients with unresectable locally advanced or metastatic disease 64 213070 Loperamide Hydrochloride Capsules USP, 2 mg (OTC) Strides Pharma Global Pte. Limited Loperamide Hydrochloride Capsules USP, 2 mg (OTC) 8/11/2021 Controls symptoms of diarrhea, including Travelers’ Diarrhea 63 201785 Varenicline Tablets, 0.5 mg and 1 mg Par Pharmaceutical, Inc. Chantix (Varenicline) Tablets, 0.5 mg and 1 mg 8/11/2021 For use as an aid to smoking cessation treatment 62 212408 Enalapril Maleate Oral Solution, 1 mg/mL Bionpharma Inc. Epaned (Enalapril Maleate) Oral Solution, 1 mg/mL 8/10/2021 For the treatment of symptomatic heart failure; and asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure 61 211776 Difluprednate Ophthalmic Emulsion, 0.05% Cipla Limited Durezol (Difluprednate) Ophthalmic Emulsion, 0.05% 8/9/2021 For the treatment of inflammation and pain associated with ocular surgery and treatment of endogenous anterior uveitis 60 204438 Glycopyrrolate Oral Solution, 1 mg/5 mL (0.2 mg/mL) Par Pharmaceutical, Inc. Cuvposa (Glycopyrrolate) Oral Solution, 1 mg/5 mL (0.2 mg/mL) 8/9/2021 To reduce chronic severe drooling in patients aged 3 to16 years with neurologic conditions associated with problem drooling. 59 211890 Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg Alkem Laboratories Limited Duexis (Ibuprofen and Famotidine) Tablets, 800 mg/26.6 mg 8/3/2021 For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers 58 211594 Buprenorphine Buccal Film, 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg Alvogen Malta Operations Ltd. Belbuca (Buprenorphine) Buccal Film, 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg 8/3/2021 For the management of pain severe enough to require daily around the clock long-term opioid treatment for which alternative treatment options are inadequate 57 212348 Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection USP, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) in Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride in 5% Dextrose & 0.225% Sodium Chloride Injection USP, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) 7/30/2021 For the treatmentpatients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride 56 212868 Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe Accord Healthcare Inc. Atropine Sulfate Injection USP, 0.25 mg/5 mL, 0.5 mg/5 mL, 1 mg/10mL 7/26/2021 For the temporary blockade of severe or life threatening muscarinic effects 55 211149 Paliperidone Palmitate Extended-Release Injectable Suspension, 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL Teva Pharmaceuticals USA, Inc. Invega Sustenna (Paliperidone Palmitate) Extended-Release Injectable Suspension, 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL 7/6/2021 For the treatment of schizophrenia in adults; schizoaffective disorder in adults 54 211238 Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, 800 mg Dr. Reddy's Laboratories Inc. Aptiom (Eslicarbazepine Acetate) Tablets, 200 mg, 400 mg, 600 mg, 800 mg 6/29/2021 For the adjunctive treatment of partial-onset seizures 53 213762 Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials Axar Pharmaceuticals, Inc. Brovana (Arformoterol Tartrate) Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials 6/22/2021 For the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema 52 213132 Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials Glenmark Pharmaceuticals Limited Brovana (Arformoterol Tartrate) Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials 6/22/2021 For the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema 51 207306 Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL Single-Dose Vial Cipla USA, Inc. Perforomist (Formoterol Fumarate) Inhalation Solution, 20 mcg/2 mL Single-Dose Vial 6/22/2021 For the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema 50 091141 Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL Single-Dose Vial Teva Pharmaceuticals USA, Inc. Perforomist (Formoterol Fumarate) Inhalation Solution, 20 mcg/2 mL Single-Dose Vial 6/22/2021 For the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema 49 214196 Etravirine Tablets, 25 mg, 100 mg, and 200 mg Amneal EU, Limited Intelence (Etravirine) Tablets, 25 mg, 100 mg, and 200 mg 6/14/2021 For the treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older 48 209330 Carfilzomib for Injection, 10 mg, 30 mg, and 60 mg Single-Dose Vials Breckenridge Pharmaceutical, Inc. Kyprolis (Carfilzomib) for Injection, 10 mg, 30 mg, and 60 mg Single-Dose Vials 6/11/2021 For the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone 47 091677 Lopinavir and Ritonavir Tablets USP, 100 mg/25 mg, 200 mg/50 mg Hetero Labs Limited Kaletra (Lopinavir and Ritonavir) Tablets, 100 mg/25 mg and 200 mg/50 mg 6/4/2021 For the treatment of HIV-1 infection in adults and pediatric patients (14 days and older) 46 212943 Tofacitinib Tablets, 10 mg Ajanta Pharma Limited Xeljanz (Tofacitinib) Tablets, 10 mg 6/1/2021 For the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis,  moderately to severely active ulcerative colitis, and active polyarticular course juvenile idiopathic arthritis
  45 212007 Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials  Exela Pharma Sciences, LLC. Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials 5/21/2021 For use as a supplement to intravenous solutions given for total parenteral nutrition (TPN) 44 201452 Lenalidomide Capsules, 5 mg, 10 mg, 15 mg and 25 mg Natco Pharma Limited Revlimid (Lenalidomide) Capsules, 5 mg, 10 mg, 15 mg and 25 mg 5/21/2021 For the treatment of multiple myeloma; transfusion-dependent anemia; mantle cell lymphoma; previously treated follicular lymphoma; previously treated marginal zone lymphoma 43 212416 Calcitonin Salmon Injection USP, 400 USP units per 2 mL (200 USP units per mL) Multi-Dose Vial  Custopharm, Inc. Miacalcin (Calcitonin Salmon) Injection USP, 400 USP units per 2 mL (200 USP units per mL) Multi-Dose Vial 5/14/2021 Treatment of symptomatic Paget’s disease; hypercalcemia; postmenopausal osteoporosis  42 209614 Enzalutamide Capsules, 40 mg  Actavis Laboratories FL, Inc Xtandi (Enzalutamide) Capsules, 40 mg 5/14/2021 For the treatment of patients with castration-resistant prostate cancer 41 214805 Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials  Milla Pharmaceuticals, Inc. Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials 5/4/2021 Indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake 40 212248 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) Single Dose Vial Fresenius Kabi USA, LLC  23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) 4/28/2021 Additive in parenteral fluid therapy for use in patients who have special problem of sodium electrolyte intake or excretion 39 212070 Sodium Chloride Injection, USP, 14.6% 50 mEq/20 mL and 100 mEq/40 mL  Fresenius Kabi USA, LLC Sodium Chloride Injection, USP 14.6% 50 mEq/20 mL and 100 mEq/40 mL 4/28/2021 For the parenteral restoration of sodium ion in patients with restricted oral intake 38 214326 Tiopronin Tablets, 100 mg Teva Pharmaceuticals USA, Inc Thiola (Tiopronin) Tablets, 100 mg 4/26/2021 For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone 37 213313 Pregabalin Extended-Release Tablets, 165 mg, 330 mg Apotex Lyrica CR (Pregabalin) Extended-Release Tablets, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia 36 213226 Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg MSN Laboratories Private Limited Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia 35 211948 Pregabalin Extended-Release Tablets, 82.5 mg Mylan Pharmaceuticals Inc. Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia 34 211889 Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg Sun Pharmaceutical Industries Limited Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia 33 211593 Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg Alvogen Pine Brook LLC Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia 32 206888 Tirofiban Hydrochloride Injection, 12.5 mg/250 mL (50 mcg/mL) Single-Dose Container Gland Pharma Limited Aggrastat (Tirofiban Hydrochloride) Injection, 12.5 mg/250 mL (50 mcg/mL) 4/8/2021 For the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy 31 211224 Macitentan Tablets, 10 mg Zydus Worldwide DMCC Opsumit (Macitentan) Tablets, 10 mg 4/6/2021 For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH 30 212296 Deoxycholic Acid Injection, 20 mg/2 mL (10 mg/mL) (Single-Dose Vial) Slayback Pharma LLC Kybella (Deoxycholic Acid) Injection, 20 mg/2 mL (10 mg/mL) 4/2/2021 For improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults 29 211344 Ibrutinib Capsules, 70 mg and 140 mg Zydus Worldwide DMCC Imbruvica (Ibrutinib) Capsules, 70 mg and 140 mg 3/31/2021 For the treatment of adult patients with mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma , Waldenström’s macroglobulinemia, marginal zone lymphoma, or chronic graft versus host disease 28 205063 Isotretinoin Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg Actavis Laboratories FL, Inc. Absorica (Isotretinoin) Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg 3/31/2021 For the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater 27 203451 50% Dextrose Injection USP, 25 g/50 mL (0.5 g/mL), Single-Dose Prefilled Syringes International Medication Systems, Limited 50% Dextrose Injection USP, 25 g/50 mL (0.5 g/mL), Single-Dose Prefilled Syringes 3/26/2021 For the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels and, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements 26 213424 Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial Accord Healthcare Inc. Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial 3/19/2021 For the temporary blockade of severe or life threatening muscarinic effects 25 214727 Potassium Chloride Injection, 10 mEq/100 mL (7.45 mg/mL), 10 mEq/50 mL (14.9 mg/mL), 20 mEq/100 mL (14.9 mg/mL), 20 mEq/50 mL (29.8 mg/mL), and 40 mEq/100 mL (29.8 mg/mL) Single-Dose Containers Nexus Pharmaceuticals Inc. Potassium Chloride Injection, 10 mEq/100 mL, 10 mEq/50 mL, 20 mEq/100 mL, 20 mEq/50 mL, and 40 mEq/100 mL 3/18/2021 For the treatment of potassium deficiency states when oral replacement is not feasible 24 213523 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP, 10 mEq/1000 mL, 20 mEq/1000 mL, 30 mEq/1000 mL, and 40 mEq/1000 mL in Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection , 10 mEq/1000 mL, 20 mEq/1000 mL, 30 mEq/1000 mL, and 40 mEq/1000 mL 3/9/2021 For patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride 23 213445 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP, 20 mEq/1,000 mL and 40 mEq/1,000 mL, Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP, 20 mEq/1,000 mL and 40 mEq/1,000 mL 3/9/2021 For patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride 22 208269 Hydrocodone Bitartrate Extended-Release Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg  Alvogen Pine Brook LLC  Hysingla ER (Hydrocodone Bitartrate Extended-Release) Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg  3/1/2021 For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate 21 214391 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Ajanta Pharma Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 20 214387 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Aurobindo Pharma Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 19 214384 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Sun Pharmaceutical Industries Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 18 214017 Droxidopa Capsules, 100 mg, 200 mg, 300 mg ScieGen Pharmaceuticals, Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 17 213911 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Alkem Laboratories Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 16 213661 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Tasman Pharma Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 15 213162 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Teva Pharmaceuticals USA, Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 14 212835 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Hikma Pharmaceuticals USA Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 13 211818 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Zydus Pharmaceuticals (USA) Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 12 211741 Droxidopa Capsules, 100 mg, 200 mg, 300 mg MSN Laboratories Private Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 11 211726 Droxidopa Capsules, 300 mg Annora Pharma Private Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 10 211652 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Lupin Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension 9 211819 Apremilast Tablets, 10 mg, 20 mg and 30 mg Unichem Laboratories Limited Otezla (Apremilast) Tablets, 10 mg, 20 mg and 30 mg 2/18/2021 For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy 8 212080 Loteprednol Etabonate Ophthalmic Gel, 0.5% Akorn Operating Company LLC Lotemax (Loteprednol) Etabonate Ophthalmic Gel, 0.5% 2/10/2021 For the treatment of post-operative inflammation and pain following ocular surgery 7 209564 Linaclotide Capsules, 145 mcg and 290 mcg Mylan Pharmaceuticals Inc. Linzess (Linaclotide) Capsules, 145 mcg and 290 mcg 2/9/2021 For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation 6 210278 Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg Glenmark Pharmaceuticals Inc., USA Qudexy XR (Topiramate Extended-Release) Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg 2/1/2021 For the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older; preventive treatment of migraine in patients 12 years of age and older 5 205971 Imiquimod Cream USP, 3.75% Taro Pharmaceutical Industries Limited Zyclara (Imiquimod) Cream, 3.75% 1/26/2021 For the topical treatment of clinically typical, visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults; for the topical treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older  4 214235 Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial Caplin Steriles Limited Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial 1/21/2021 For the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia; as an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention  3 210473 Epoprostenol for Injection, 0.5 mg/Vial and 1.5 mg/Vial Sun Pharmaceutical Industries Limited Veletri (Epoprostenol for Injection), 0.5 mg/Vial and 1.5 mg/Vial 1/15/2021 For the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity 2 206604 Ferumoxytol Injection, 510 mg Iron/17 mL (30 mg/mL) Single-Dose Vials Sandoz Inc. Feraheme (Ferumoxytol) Injection, 510 mg Iron/17 mL (30 mg/mL) Single-Dose Vials 1/15/2021 For the treatment of iron deficiency anemia in adult patients who: have intolerance to oral iron or have had unsatisfactory response to oral iron; or who have chronic kidney disease  1 213256 Levothyroxine Sodium Capsules, 88 mcg, 100 mcg, and 125 mcg Teva Pharmaceuticals USA, Inc.  Tirosint (Levothyroxine Sodium) Capsules, 88 mcg, 100 mcg, and 125 mcg 1/6/2021 For adults and pediatric patients 6 years and older with hypothyroidism

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