86 215846 Sodium Nitroprusside in 0.9% Sodium Chloride Injection, 10 mg/50 mL (0.2 mg/mL), 20 mg/100 mL (0.2 mg/mL), and 50 mg/100 mL (0.5 mg/mL) Single-Dose Vials Hainan Poly Pharm. Co., Ltd. Nipride RTU (Sodium Nitroprusside) in 0.9% Sodium Chloride Injection 8/26/2022 For the immediate reduction of blood pressure; for producing controlled hypotension to reduce bleeding during surgery; for the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure 85 204964 Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg Lupin Limited Banzel (Rufinamide) Tablets 8/17/2022 For the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults 84 215737 Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Akorn Operating Company LLC Cetrotide (Cetrorelix Acetate) for Injection 8/12/2022 For the inhibition of premature LH surges in women undergoing controlled ovarian stimulation 83 213692 Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg Teva Pharmaceuticals USA, Inc. Rexulti (Brexpiprazole) Tablets 8/11/2022 For use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults 82 211873 Estradiol Gel, 0.1% Chemo Research S.L. Divigel (Estradiol) Gel 8/10/2022 For the treatment of moderate to severe vasomotor symptoms due to menopause 81 212138 Empagliflozin Tablets, 10 mg and 25 mg Zydus Pharmaceuticals (USA) Inc. Jardiance (Empagliflozin) Tablets 8/3/2022 Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 80 214934 Minocycline for Injection USP, 100 mg per vial (Single-Dose Vial) Nexus Pharmaceuticals, Inc. Minocin (Minocycline) for Injection 7/22/2022 For the treatment of infections caused by certain Gram-negative and Gram-positive bacteria, and others, when bacteriologic testing indicates appropriate susceptibility 79 214489 Azilsartan Medoxomil Tablets, 40 mg and 80 mg Lupin Limited Edarbi (Azilsartan Medoxomil) Tablets 7/20/2022 For the treatment of hypertension to lower blood pressure 78 212722 Pirfenidone Tablets, 267 mg, 534 mg and 801 mg Laurus Labs Limited Esbriet (Pirfenidone) Tablets 7/19/2022 For the treatment of idiopathic pulmonary fibrosis 77 214475 Fenoprofen Calcium Capsules USP, 400 mg Rising Pharma Holdings, Inc. Nalfon (Fenoprofen Calcium) Capsules 7/18/2022 For the relief of mild to moderate pain in adults; relief of the signs and symptoms of rheumatoid arthritis; relief of the signs and symptoms of osteoarthritis 76 212789 Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid for Oral Solution, 10 mg/3.5 g/12 g per Packet Hetero Labs Limited Unit V Prepopik (Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid) for Oral Solution 7/18/2022 For the cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older 75 212198 Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg Zydus Pharmaceuticals (USA) Inc. Synjardy (Empagliflozin and Metformin Hydrochloride) Tablets 7/7/2022 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease 74 215370 Multiple Electrolytes Injection Type 1 USP, pH 5.5, Single-Dose Containers Fresenius Kabi USA, LLC Plasma-Lyte 148 (Multiple Electrolytes) Injection  6/29/2022 Indicated as a source of water and electrolytes or as an alkalinizing agent 73 212206 Abiraterone Acetate Tablets USP, 125 mg Teva Pharmaceuticals USA, Inc. Yonsa (Abiraterone Acetate) Tablets  6/24/2022 In combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer 72 207619 Cabazitaxel Injection, 60 mg/1.5 mL (40 mg/mL) Breckenridge Pharmaceutical, Inc. Jevtana (Cabazitaxel) Injection 6/23/2022 In combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen 71 214748 Brivaracetam Tablets, 10 mg, 25 mg,50 mg, 75 mg, and 100 mg Sunshine Lake Pharma Co. Limited Briviact (Brivaracetam) Tablets 6/9/2022 For the treatment of partial-onset seizures in patients 4 years of age and older 70 214071 Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) Strides Pharma Global Pte. Limited Infants’ Advil (Ibuprofen Oral Suspension) (OTC) 6/9/2022 For the temporary reducuction of fever, relief minor aches and pains due to the common cold, flu, headaches and toothaches 69 215371 Multiple Electrolytes Injection Type 1 USP, pH 7.4 Single-Dose container Fresenius Kabi USA, LLC Plasma-Lyte 148 (Multiple Electrolytes) Injection  6/8/2022 Indicated as a source of water and electrolytes or as an alkalinizing agent 68 216120 Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL American Regent, Inc. Atropine Sulfate Injection 5/26/2022 For the temporary blockade of severe or life threatening muscarinic effects 67 214073 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram/vial Zydus Pharmaceuticals (Usa) Inc. Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 66 202596 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram/vial Dr. Reddy'S Laboratories Limited Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 65 202111 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram/vial Hospira Inc Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 64 214632 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram/vial Eugia Pharma Specialities Limited Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 63 211899 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial Waverley Pharma International Inc. Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 62 211090 Pemetrexed for Injection USP, 1 gram/vial Biocon Limited Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 61 209851 Pemetrexed for Injection USP, 750 mg/vial, Apotex Inc Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 60 209085 Pemetrexed for Injection USP, 1 gram/vial Apotex Inc Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 59 208696 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial Jiangsu Hansoh Pharmaceutical Group Co Ltd Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 58 207352 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial Nang Kuang Pharmaceutical Corporation Ltd Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 57 204890 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial Qilu Pharmaceutical Corporation Ltd Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 56 203774 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial Apotex Inc. Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 55 203485 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram/vial Accord Healthcare Inc Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 54 090384 Pemetrexed for Injection USP, 100 mg/vial, 500 mg/vial, 750 mg/vial, 1 gram/vial Fresenius Kabi Usa, Llc Alimta (Pemetrexed for Injection) 5/25/2022 For the treatment of non-squamous non-small cell lung cancer and mesothelioma 53 208768 Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL) Single-Dose vial Par Sterile Products, LLC Noxafil (Posaconazole) IV solution 5/25/2022 For the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised 52 214672 Lacosamide Oral Solution USP, 10 mg/mL Alkem Laboratories Limited Vimpat (Lacosamide) Oral Solution 5/19/2022 For the treatment of partial-onset seizures in patients 4 years of age and older 51 214271 Iodixanol Injection USP, 270 mg Iodine/mL and 320 mg Iodine/mL Single Dose Bottles Jiangsu Hengrui Pharmaceuticals Co., Ltd. Visipaque (Iodixanol) Injection 5/19/2022 Radiographic contrast agent indicated for certain intra-arterial and intravenous procedures 50 214293 Estradiol and Progesterone Capsules, 1 mg/100 mg Amneal Pharmaceuticals of New York, LLC Bijuva (Estradiol and Progesterone) Capsules 5/16/2022 For the treatment of moderate to severe vasomotor symptoms due to menopause 49 214585 Mesalamine Extended Release Capsules USP, 500 mg Sun Pharma Industries Limited Pentasa (Mesalamine) Extended Release Capsules 5/11/2022 For the induction of remission and for the treatment of adult patients with mildly to moderately active ulcerative colitis 48 207714 Diclofenac Topical Solution 2% (w/w) Apotex Inc. Pennsaid (Diclofenac) Topical Solution 5/6/2022 For the treatment of the pain of osteoarthritis of the knee 47 216249 Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package Gland Pharma Limited Zinc Sulfate Injection 5/3/2022 As a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated 46 213823 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Baxter Healthcare Corporation Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 45 212825 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Eugia Pharma Specialities Limited Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 44 210824 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Qilu Pharmaceutical Corporation Ltd Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 43 210204 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Zydus Pharmaceuticals (USA) Inc. Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 42 209659 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Fresenius Kabi USA, LLC Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 41 208392 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Pharmascience Inc. Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 40 205857 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Teva Pharmaceuticals USA, Inc. Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 39 205533 Bortezomib for Injection, 3.5 mg per vial (Single-Dose Vial) Apotex Inc. Velcade (Bortezomib) for Injection 5/2/2022 For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma 38 215398 Bexarotene Gel, 1% Amneal Pharmaceuticals LLC Targretin (Bexarotene) Gel 4/27/2022 For the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies 37 214596 Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Vials Cipla Limited AquaMEPHYTON (Phytonadione) Injection 4/22/2022 For the treatment of certain coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity 36 212424 Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Ampules Cipla Limited AquaMEPHYTON (Phytonadione) Injection 4/22/2022 For the treatment of certain coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity 35 213236 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe Accord Healthcare Inc. Lexiscan (Regadenoson) Injection 4/11/2022 Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress 34 213210 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe Dr. Reddy’s Laboratories Limited Lexiscan (Regadenoson) Injection 4/11/2022 Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress 33 212806 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe Hong Kong King-Friend Industrial Company Limited Lexiscan (Regadenoson) Injection 4/11/2022 Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress 32 207604 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe Apotex Inc. Lexiscan (Regadenoson) Injection 4/11/2022 Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress 31 214082 Cysteine Hydrochloride Injection USP, 500 mg/10 mL (50 mg/mL), Single-dose Vial Eton Pharmaceuticals, Inc. Elcys (Cysteine Hydrochloride) Injection 4/8/2022 Indicated to meet the 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 30 214301 Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL) Indoco Remedies Limited Vimpat (Lacosamide) Injection 4/7/2022 For the treatment of partial-onset seizures in patients 17 years of age and older 29 215586 Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg Ricon Pharma LLC Bidil (sosorbide Dinitrate and Hydralazine Hydrochloride) Tablets 4/6/2022 For the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status 28 091087 Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% Sandoz Inc. Combigan (Brimonidine Tartrate and Timolol Maleate) Ophthalmic Solution 4/4/2022 For the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP 27 209997 Sodium Phosphates Injection USP, 15 mM P/5 mL (3 mM P/mL), 45 mM P/15 mL (3 mM P/mL) and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials Fresenius Kabi USA, LLC Sodium Phosphates Injection 3/30/2022 As a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake 26 210332 Lactated Ringer's and 5% Dextrose Injection, USP, Single-Dose Container Fresenius Kabi USA, LLC Lactated Ringer's and 5% Dextrose Injection 3/28/2022 For the parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient 25 204787 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Hetero Labs Limited Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 24 204857 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Amneal Pharmaceuticals Of New York, LLC Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 23 204921 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Msn Laboratories Private Limited Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 22 205006 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Glenmark Pharmaceuticals Ltd Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 21 205031 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Sun Pharmaceutical Industries Limited Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 20 208308 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Indoco Remedies Limited Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 19 205237 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Sciegen Pharmaceuticals Inc Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 18 204974 Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg Alembic Pharmaceuticals Limited Vimpat (lacosamide) Tablets 3/17/2022 Treatment of partial-onset seizures in patients 4 years of age and older 17 211699 Breyna (Budesonide and Formoterol Fumarate Dihydrate) Inhalation Aerosol 160/4.5 mcg/actuation and 80/4.5 mcg/actuation Mylan Pharmaceuticals Inc., a Viatris Company Symbicort (Budesonide and Formoterol Fumarate Dihydrate) Inhalation Aerosol 3/15/2022 For the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema 16 206497 Methylphenidate Transdermal System, 1.1 mg/hr, 1.6 mg/hr, 2.2 mg/hr, and 3.3 mg/hr Mylan Technologies Inc. Daytrana Transdermal System 3/14/2022 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) 15 212472 Doxylamine Succinate and Pyridoxine Hydrochloride Extended-Release Tablets, 20 mg/20 mg Actavis Laboratories FL, Inc. Bonjesta (Doxylamine Succinate and Pyridoxine Hydrochloride) Extended-Release Tablets 3/1/2022 For the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management 14 212025 Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use glass cartridge for use with a reusable pen injector (APOKYN Pen) Sage Chemical, Inc. Apokyn (Apomorphine) Injection 2/23/2022 For the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease 13 211582 Dapagliflozin Tablets, 5 mg and 10 mg Zydus Pharmaceuticals (USA) Inc. Farxiga (Dapagliflozin) Tablets 2/22/2022 As an adjunct to diet and exercise to improve glycemic control 12 206119 Tolvaptan Tablets, 15 mg and 30 mg Par Pharmaceutical, Inc. Samsca (Tolvaptan) Tablets 2/15/2022 Treatment of clinically significant hypervolemic and euvolemic hyponatremia including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) 11 214982 Digoxin Tablets USP, 0.0625 mg, 0.125 mg, and 0.25 mg Aurobindo Pharma Limited Lanoxin (Digoxin) Tablets 2/8/2022 For the treatment of mild to moderate heart failure in adults 10 212955 Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL), Single-Dose Vials Purdue Pharma L.P. Revex (Nalmefene) Injection 2/8/2022 For the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids; for management of known or suspected opioid overdose 9 203347 Maraviroc Tablets, 150 mg and 300 mg Hetero Labs Limited, Unit III Selzentry (Maraviroc) Tablets 2/7/2022 For the treatment of only CCR5- tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg 8 205894 Cyclosporine Ophthalmic Emulsion, 0.05% Mylan Pharmaceuticals Inc. Restasis) Cyclosporine Ophthalmic Emulsion 2/2/2022 To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca 7 210876 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg Teva Pharmaceuticals USA, Inc. Mydayis (Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate)Extended-Release Capsules 1/31/2022 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older 6 078479 Brimonidine Tartrate Ophthalmic Solution, 0.15% Apotex Inc. Alphagan P (Brimonidine Tartrate) Ophthalmic Solution 1/31/2022 For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension 5 211353 Sofosbuvir Tablets, 400 mg Teva Pharmaceuticals USA, Inc Sovaldi (Sofosbuvir) Tablets 1/27/2022 For the treatment of adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen 4 213212 Carbidopa, Levodopa and Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg Rising Pharma Holdings, Inc. Stalevo (Carbidopa, Levodopa and Entacapone) Tablets 1/25/2022 For the treatment of Parkinson's disease 3 212759 Pirfenidone Tablets, 267 mg and 801 mg Teva Pharmaceuticals, USA, Inc. Esbriet (Pirfenidone) Tablets 1/25/2022 For the treatment of idiopathic pulmonary fibrosis 2 212730 Pirfenidone Tablets, 267 mg and 801 mg Accord Healthcare Inc. Esbriet (Pirfenidone) Tablets 1/25/2022 For the treatment of idiopathic pulmonary fibrosis 1 212569 Pirfenidone Capsules, 267 mg Amneal EU, Limited Esbriet (Pirfenidone) Capsules 1/3/2022 For the treatment of idiopathic pulmonary fibrosis

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