90 208237 Memantine and Donepezil Hydrochloride Extended-Release Capsules, 21 mg/10 mg and 28 mg/10 mg ANI Pharmaceuticals, Inc. Namzaric (Memantine and Donepezil Hydrochloride) Extended-Release Capsules 12/15/2023 For the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily 89 208070 Dabigatran Etexilate Capsules, 75 mg, 110 mg,  150 mg Apotex, Inc. Pradaxa (Dabigatran Etexilate) Capsules 12/15/2023 To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment and prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE); for the prophylaxis of DVT and PE in certain patients; for the treatment of and to reduce the recurrance of venous thromboembolic events  88 217987 Vasopressin in 5% Dextrose Injection, 20 units/100 mL  (0.2 units/mL) Single-Dose Vials Cipla Limited Vasostrict (Vasopressin) Injection 12/6/2023 To increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines 87 215636 Methylene Blue Injection USP, 10 mg/2 mL (5 mg/mL) and  50 mg/10 mL (5 mg/mL) Single-Dose Vials Zydus Worldwide DMCC ProvayBlue (Methylene Blue) Injection 12/5/2023 For the treatment of pediatric and adult patients with acquired methemoglobinemia 86 206027 Bromfenac Ophthalmic Solution, 0.07% Lupin Limited Prolensa (Bromfenac) Ophthalmic Solution 11/22/2023 For the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery 85 211097 Teriparatide Injection USP, 600 mcg/2.4 mL (250 mcg/mL) Single-Patient-Use Prefilled Pens Apotex Inc. Forteo (Teriparatide) Injection 11/16/2023 For the rreatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy 84 208569 Teriparatide Injection USP, 600 mcg/2.4 mL (250 mcg/mL) Single-Patient-Use Prefilled Pens Teva Pharmaceuticals USA, Inc. Forteo (Teriparatide) Injection 11/16/2023 For the rreatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy 83 213516 Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Jubilant DraxImage Inc Technetium TC 99M sulfur colloid kit 11/9/2023 Diagnostic radiopharmaceutical to assist in the localization of lymph nodes draining a primary tumor in adult patients with breast cancer; for evaluation of peritoneo-venous (LeVeen) shunt patency in adults; imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow; studies of esophageal transit and gastroesophageal reflux; detection of pulmonary aspiration of gastric contents 82 217713 Pazopanib Tablets, 200 mg Apotex Inc Votrient (Pazopanib) Tablets 10/19/2023 For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy 81 217517 Pazopanib Tablets, 200 mg Teva Pharmaceuticals, Inc. Votrient (Pazopanib) Tablets 10/19/2023 For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy 80 215837 Pazopanib Tablets, 200 mg Sun Pharmaceutical Industries Limited Votrient (Pazopanib) Tablets 10/19/2023 For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy 79 217155 Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) Amneal EU, Limited Tranexamic Acid 10/16/2023 Antifibrinolytic indicated in patients with hemophilia for shortterm use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction 78 217134 Iopamidol Injection USP, 41% Single-Dose Vial Hainan Poly Pharm. Co., Ltd. Isovue-200 (Iopamidol) Injection 9/27/2023 For angiography throughout the cardiovascular system; coronary arteriography and ventriculography; pediatric angiocardiography; selective visceral arteriography and aortography; peripheral venography; adult and pediatric intravenous excretory urography; intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging 77 216878 Tofacitinib Oral Solution, 1 mg/mL Slayback Pharma LLC Xeljanz (Tofacitinib) Oral Solution 9/25/2023 For the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Ulcerative Colitis; Polyarticular Course Juvenile Idiopathic Arthritis 76 215709 Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL) Single-Dose Vials Nexus Pharmaceuticals Inc. AK-FLUOR (Fluorescein) Injection 9/25/2023 Indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature 75 216081 Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) Imaging Bulk Package Jiangsu Hengrui Pharmaceuticals Co., Ltd. Gadavist (Gadobutro) Injection 9/8/2023 For use with magnetic resonance imaging to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system; to assess the presence and extent of malignant breast disease; to evaluate known or suspected supra-aortic or renal artery disease; to assess myocardial perfusion (stress, rest) and late gadolinium enhancement  74 217174 Calcium Gluconate Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL) Single-Dose Containers Amneal EU, Limited Calcium Gluconate Injection 9/5/2023 For the treatment of acute symptomatic hypocalcemia 73 215572 Spironolactone Oral Suspension, 25 mg/5 mL Amneal Pharmaceuticals LLC Carospir (Spironolactone) Oral Suspension 9/5/2023 For the treatment of NYHA Class III-IV heart failure and reduced ejection fraction ; to use as an add-on therapy for the treatment of hypertension, to lower blood pressure; for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions 72 215570 Palbociclib Tablets, 75 mg, 100 mg, and 125 mg Synthon Pharmaceuticals, Inc. Ibrance (Palbociclib) Tablets 8/28/2023 For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or fulvestrant in patients with disease progression following endocrine therapy 71 217442 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Ascent Pharmaceuticals, Inc Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 70 217194 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Alkem Laboratories Limited Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 69 217068 Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Ascent Pharmaceuticals Inc Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 68 216944 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Apotex Inc Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 67 216266 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Prinston Pharmaceutical Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 66 215802 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Lannett Company, Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 65 215415 Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Teva Pharmaceuticals USA, Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 64 215330 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Rhodes Pharmaceuticals L.P. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 63 214547 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Norwich Pharmaceuticals, Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 62 214484 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Sun Pharmaceutical Industries, Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 61 214134 Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Sun Pharmaceutical Industries, Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 60 211840 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg SpecGx LLC Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 59 202835 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Mylan Pharmaceuticals Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 58 202830 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Amneal Pharmaceuticals LLC Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 57 202827 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Hikma Pharmaceuticals USA Inc. Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 56 202802 Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg Actavis Elizabeth LLC Vyvanse (Lisdexamfetamine Dimesylate ) Capsules 8/25/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults 55 215609 Tretinoin Gel (Microsphere), 0.08% Encube Ethicals Private Limited Retin-A-Micro (Tretinoin) Gel Microsphere 8/22/2023 For the topical treatment of acne vulgaris 54 216541 Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package B. Braun Medical, Inc. Calcium Gluconate in Sodium Chloride Injection 8/21/2023 For the treatment of acute symptomatic hypocalcemia 53 214640 Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg Xiromed Pharma Espana, S.L. Balcoltra (Levonorgestrel and Ethinyl Estradiol and Ferrous Bisglycinate) Tablets 8/16/2023 For use by females of reproductive potential to prevent pregnancy 52 215266 Halobetasol Propionate Topical Foam, 0.05% Padagis Israel Pharmaceuticals Ltd. Lexette (Halobetasol Propionate) Topical Foam 8/11/2023 For the topical treatment of plaque psoriasis in patients twelve (12) years of age and older 51 215081 Lifitegrast Ophthalmic Solution, 5% Micro Labs Limited Xiidra (Lifitegrast) Ophthalmic Solution 8/4/2023 For the treatment of the signs and symptoms of dry eye disease 50 206081 Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 2.5 mg/1,000 mg, and 5 mg/1,000 mg Sun Pharmaceutical Industries Limited Kombiglyze XR (Saxagliptin and Metformin Hydrochloride) Extended-Release Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate 49 206078 Saxagliptin Tablets, 2.5 mg and 5 mg Sun Pharmaceutical Industries Limited Onglyza (Saxagliptin) Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 48 205994 Saxagliptin Tablets, 2.5 mg and 5 mg Glenmark Pharmaceuticals Limited Onglyza (Saxagliptin) Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 47 205981 Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 2.5 mg/1,000 mg, and 5 mg/1,000 mg Mylan Pharmaceuticals Inc. Kombiglyze XR (Saxagliptin and Metformin Hydrochloride) Extended-Release Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate 46 205980 Saxagliptin Tablets, 2.5 mg and 5 mg Mylan Pharmaceuticals Inc. Onglyza (Saxagliptin) Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 45 205972 Saxagliptin Tablets, 2.5 mg and 5 mg Aurobindo Pharma Limited Onglyza (Saxagliptin) Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 44 205941 Saxagliptin Tablets, 2.5 mg and 5 mg Amneal Pharmaceuticals of NY, LLC Onglyza (Saxagliptin) Tablets 7/31/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 43 208980 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial Zydus Pharmaceuticals (USA) Inc. Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 42 215698 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial Kindos Pharmaceuticals Co., Ltd.   Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 41 215334 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial Amneal EU, Limited Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 40 213672 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial Eugia Pharma Specialities Limited Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 39 211901 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial MSN Laboratories Private Limited Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 38 205197 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial Teva Pharmaceuticals USA, Inc. Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 37 205182 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial Dr. Reddy's Laboratories Limited Mozobil (Plerixafor) Injection 7/24/2023 In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma 36 215893 Ponatinib Tablets, 15 mg and 45 mg  Apotex Inc. Iclusig (Ponatinib) Tablets 7/14/2023 For the treatment of adult patients with Chronic phase chronic myeloid leukemia (CML); accelerated phase or blast phase CML or Philadelphia chromosome positive acute lymphoblastic leukemia ; T315I-positive CML or T315I-positive Ph+ ALL 35 216947 Ertugliflozin Tablets, 5 mg and 15 mg Aurobindo Pharma Limited Steglatro (Ertugliflozin) Tablets 7/13/2023 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 34 213369 Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg, and 600 mg Apotex Inc. Oxtellar XR (Oxcarbazepine) Extended-Release Tablets 7/13/2023 For the treatment of partial-onset seizures in patients 6 years of age and older 33 213195 Naltrexone for Extended-Release Injectable Suspension, 380 mg/vial, Single-Dose Vial Teva Pharmaceuticals USA, Inc. Vivitrol (Naltrexone) for Extended-Release Injectable Suspension 7/6/2023 For the prevention of relapse to opioid dependence, following opioid detoxification 32 210659 Alcaftadine Ophthalmic Solution, 0.25% (OTC) Eugia Pharma Specialities Limited Lastacaft (Alcaftadine) Ophthalmic Solution 6/23/2023 Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander 31 209253 Amphetamine Extended-Release Orally Disintegrating Tablets, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg Actavis Laboratories FL, Inc. Adzenys XR-ODT (Amphetamine) Extended-Release Orally Disintegrating Tablets 6/22/2023 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older 30 211287 Tiotropium Bromide Inhalation Powder, 18 mcg/capsule Lupin Inc Spiriva HandiHaler (Tiotropium Bromide) Inhalation Powder 6/20/2023 For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema 29 215902 Safinamide Tablets, 50 mg and 100 mg Aurobindo Pharma Limited Xadago (Safinamide) Tablets 6/14/2023 Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes 28 215035 Amlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL) Amneal Pharmaceuticals LLC Katerzia (Amlodipine Benzoate) Oral Suspension 6/13/2023 For the treatment of hypertension and coronary artery disease 27 214008 Trifluridine and Tipiracil Tablets, 15 mg/6.14 mg and 20 mg/8.19 mg Natco Pharma Limited Lonsurf (Trifluridine and Tipiracil) Tablets 6/13/2023 For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy 26 214337 Sugammadex Injection, 200 mg/2 mL (100 mg/mL), 500 mg/5 mL (100 mg/mL) Single-Dose Vial Aspiro Pharma Limited Bridion (Sugammadex) Injection 6/9/2023 Reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery 25 217252 Baclofen Oral Suspension, 25 mg/5 mL (5 mg/mL) Slayback Pharma LLC Fleqsuvy (Baclofen) Oral Suspension 6/8/2023 Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity and some value in patients with spinal cord injuries and other spinal cord diseases 24 215017 Obeticholic Acid Tablets, 5 mg and 10 mg MSN Laboratories Private Limited Ocaliva (Obeticholic Acid ) Tablets 5/30/2023 For the treatment of adult patients with primary biliary cholangitis 23 214980 Obeticholic Acid Tablets, 5 mg and 10 mg Lupin Limited Ocaliva (Obeticholic Acid ) Tablets 5/30/2023 For the treatment of adult patients with primary biliary cholangitis 22 214862 Obeticholic Acid Tablets, 5 mg and 10 mg Apotex Inc. Ocaliva (Obeticholic Acid ) Tablets 5/30/2023 For the treatment of adult patients with primary biliary cholangitis 21 091076 Diazepam Rectal Gel Rectal Delivery System, 10 mg and 20 mg Novel Laboratories, Inc. Diastat AcuDial (Diazepam) Rectal Gel Rectal Delivery System 5/30/2023 For the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity 20 216435 Edetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial Casper Pharma LLC Calcium Disodium Versenate Injection 5/3/2023 For the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults 19 217213 Methsuximide Capsules USP, 300 mg Novitium Pharma LLC Celontin (Methsuximide) Capsules 5/1/2023 For the control of absence (petit mal) seizures that are refractory to other drugs 18 213267 Thalidomide Capsules USP, 50 mg, 100 mg, 150 mg, 200 mg Natco Pharma Limited Thalomid (Thalidomide) Capsules 4/27/2023 For the treatment of patients with newly diagnosed multiple myeloma; for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL); as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence 17 216159 Midazolam in 0.9% Sodium Chloride Injection, 50 mg/50 mL (1mg/mL) and 100 mg/100 mL (1 mg/mL) Single-Dose Bags Hikma Pharmaceuticals USA Inc. Midazolam in 0.9% Sodium Chloride Injection 4/17/2023 Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting 16 204379 Estradiol Transdermal System USP, 0.014 mg/day Zydus Noveltech, Inc Menostar (Estradiol) Transdermal System 4/17/2023 For the prevention of postmenopausal osteoporosis 15 215933 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Akorn Operating Company LLC Alrex (Loteprednol Etabonate) Ophthalmic Suspension 4/12/2023 For the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis 14 215328 Budesonide Rectal Foam, 2 mg/dose Padagis Israel Pharmaceuticals Ltd. Uceris (Budesonide) Rectal Foam 4/12/2023 For the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge 13 214226 Tenofovir Alafenamide Tablets, 25 mg Lupin Limited Vemlidy (Tenofovir Alafenamide) Tablets 3/30/203 For the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease 12 214688 Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam 3/21/2023 For the topical treatment of plaque psoriasis in patients 12 years and older 11 209738 Tofacitinib Tablets, 5 mg and 10 mg Micro Labs Limited Xeljanz (Tofacitinib) Tablets 3/13/2023 For the treatment of adult patients with moderately to severely active rheumatoid arthritis; active psoriatic arthritis; moderately to severely active ulcerative colitis 10 205770 Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125 mg/125 mg Par Pharmaceutical, Inc. Pylera (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride) Capsules 3/6/2023 For the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori 9 214836 Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) L. Perrigo Company Advil Dual Action with Acetaminophen (Acetaminophen and Ibuprofen) Tablets (OTC) 2/28/2023 Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis 8 217219 Tiopronin Delayed-Release Tablets, 100 mg and 300 mg Par Pharmaceutical, Inc. Thiola (Tiopronin) EC Tablets 2/24/2023 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 7 215408 Doxepin Hydrochloride Cream, 5% Teva Pharmaceuticals Development, Inc. Zonalon (Doxepin Hydrochloride) Cream 2/17/2023 For the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus 6 216167 Topiramate Extended-Release Capsules, 200 mg Zydus Pharmaceuticals (USA) Inc. Trokendi XR (Topiramate) Extended-Release Capsules 2/9/2023 Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older; preventive treatment of migraine in patients 12 years of age and older 5 213947 Tirofiban Hydrochloride Injection, 5 mg/100 mL (50 mcg/mL), Single-Dose Containers Nexus Pharmaceuticals, Inc. Aggrastat (Tirofiban Hydrochloride) Injection 2/7/2023 To reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome 4 213073 Cysteine Hydrochloride Injection USP, 725 mg/10 mL (72.5 mg/mL) Nivagen Pharmaceuticals, Inc. Cysteine Hydrochloride Injection 1/26/2023 For use as an additive to amino acids solutions to meet nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN 3 211452 Morphine Sulfate Injection USP, 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, 15 mg/mL Hikma Pharmaceuticals International Limited Morphine Sulfate Injection 1/12/2023 For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate 2 216496 Phenylephrine Hydrochloride Ophthalmic Solution USP, 10 % Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution 1/11/2023 For the purpose of dilating the pupils 1 215908 Nitisinone Capsules, 2 mg, 5 mg, 10 mg, and 20 mg Torrent Pharma Inc. Orfadin (Nitisinone) Capsules 1/9/2023 For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine

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