First Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.
“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.
Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.
First-Time Generic Drug Approvals 2022*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 106 | 215924 | Dichlorphenamide Tablets USP, 50 mg | Torrent Pharma Inc. | Keveyis (Dichlorphenamide) Tablets | 12/29/2022 | For the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants |
| 105 | 216145 | Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package | Fresenius Kabi USA, LLC | Zinc Sulfate Injection | 12/27/2022 | A source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| 104 | 214302 | Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg | Zydus Worldwide DMCC | Uptravi (Selexipag) Tablets | 12/21/2022 | For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH |
| 103 | 216324 | Cupric Sulfate Injection USP, 4 mg/10 mL (0.4 mg/mL) Pharmacy Bulk Package | American Regent, Inc. | Cupric Sulfate Injection | 12/16/2022 | For use as a supplement to intravenous solutions given for TPN to prevent and treat copper deficiency |
| 102 | 205574 | Bendamustine Hydrochloride for Injection, USP, 25 mg/vial and 100 mg/vial Single-Dose Vials | Accord Healthcare Inc. | Treanda (Bendamustine Hydrochloride) Injection | 12/7/2022 | For the treatment of Chronic lymphocytic leukemia (CLL); Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen |
| 101 | 205376 | Bendamustine Hydrochloride for Injection, USP, 25 mg/vial and 100 mg/vial Single-Dose Vials | Dr. Reddy’s Laboratories, Inc. | Treanda (Bendamustine Hydrochloride) Injection | 12/7/2022 | For the treatment of Chronic lymphocytic leukemia (CLL); Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen |
| 100 | 215061 | Gadobutrol Injection, 2 mmol/2 mL (1 mmol/mL), 7.5 mmol/7.5 mL (1 mmol/mL), 10 mmol/10 mL (1 mmol/mL), 15 mmol/15 mL (1 mmol/mL) Single-Dose Vial | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Gadavist (Gadobutrol) Injection | 11/17/2022 | A gadolinium-based contrast agent indicated for use with magnetic resonance imaging |
| 99 | 214913 | Vancomycin Hydrochloride for Oral Solution USP, 25 mg/mL and 50 mg/mL | Alkem Laboratories Limited | Firvanq Kit (Vancomycin Hydrochloride) for Oral Solution | 11/14/2022 | Indicated in adults and pediatric patients less than 18 years of age for the treatment of: Clostridium difficile-associated diarrhea, Enterocolitis caused by Staphylococcus aureus |
| 98 | 212710 | Penciclovir Cream, 1% | Teva Pharmaceuticals USA, Inc. | Denavir (Penciclovir) Cream | 11/9/2022 | Indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older |
| 97 | 212071 |
Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vial | Exela Pharma Sciences, LLC | Cupric Chloride in Plastic Container Injection | 10/31/2022 | For use as a supplement to intravenous solutions given for total parenteral nutrition |
| 96 | 202073 | Darunavir Tablets, 600 mg and 800 mg | Lupin Limited | Prezista (Darunavir) Tablets | 9/29/2022 | For the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older |
| 95 | 209485 | Mirabegron Extended-Release Tablets, 25 mg and 50 mg | Lupin Limited | Myrbetriq (Mirabegron) Extended-Release Tablets | 9/29/2022 | For the treatment of overactive bladder in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| 94 | 209532 | Gefitinib Tablets, 250 mg | Apotex Inc. | Iressa (Gefitinib) Tablets | 9/23/2022 | For the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations |
| 93 | 210596 | Vyduo (Nebivolol and Valsartan) Tablets, 5 mg/80 mg | Prinston Pharmaceutical Inc. | Byvalson (Nebivolol and Valsartan) Tablets | 9/19/2022 | For the treatment of hypertension, to lower blood pressure |
| 92 | 215433 | Tazarotene Gel, 0.05% | Cosette Pharmaceuticals, Inc. | Tazorac (Tazarotene) Gel | 9/13/2022 | For the topical treatment of plaque psoriasis of up to 20% body surface area involvement |
| 91 | 214136 | Tazarotene Gel, 0.1% | Cosette Pharmaceuticals, Inc. | Tazorac (Tazarotene) Gel | 9/13/2022 | For the topical treatment of plaque psoriasis of up to 20% body surface area involvement; for the topical treatment of mild to moderate facial acne vulgaris |
| 90 | 213984 | Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg and 6 mg | Zydus Pharmaceuticals USA Inc. | Vraylar (Cariprazine) Capsules | 9/9/2022 | For the treatment of schizophrenia in adults; for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults;for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults |
| 89 | 208256 | Roflumilast Tablets, 250 mcg and 500 mcg | MSN Laboratories Private Limited | Daliresp (Roflumilast) Tablets | 9/7/2022 | A treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| 88 | 211135 | Riociguat Tablets, 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg | MSN Laboratories Private Limited | Adempas (Riociguat) Tablets | 9/1/2022 | For the treatment of adults with persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; for the treatment of pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class and to delay clinical worsening |
| 87 | 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 |
| 86 | 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 |
| 85 | 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 |
| 84 | 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 |
| 83 | 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 |
| 82 | 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 |
| 81 | 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 |
| 80 | 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 |
| 79 | 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 |
| 78 | 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 |
| 77 | 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 |
| 76 | 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 |
| 75 | 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 |
| 74 | 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 |
| 73 | 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 |
| 72 | 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 |
| 71 | 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 |
| 70 | 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 |
| 69 | 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 |
| 68 | 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 |
| 67 | 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 |
| 66 | 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 |
| 65 | 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 |
| 64 | 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 |
| 63 | 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 |
| 62 | 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 |
| 61 | 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 |
| 60 | 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 |
| 59 | 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 |
| 58 | 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 |
| 57 | 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 |
| 56 | 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 |
| 55 | 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 |
| 54 | 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 |
| 53 | 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 |
| 52 | 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 |
| 51 | 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 |
| 50 | 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 |
| 49 | 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 |
| 48 | 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 |
| 47 | 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 |
| 46 | 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 |
| 45 | 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 |
| 44 | 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 |
| 43 | 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 |
| 42 | 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 |
| 41 | 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 |
| 40 | 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 |
| 39 | 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 |
| 38 | 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 |
| 37 | 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 |
| 36 | 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 |
| 35 | 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 |
| 34 | 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 |
| 33 | 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 |
| 32 | 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 |
| 31 | 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 |
| 30 | 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 |
| 29 | 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 |
| 28 | 213792 | Ioflupane I-123 Injection, 185 MBq (5 mCi)/2.5 mL [74 MBq (2 mCi)/mL] Single-Dose Vial | Curium US, LLC | DaTscan (Ioflupane I-123) Injection | 3/30/2022 | For striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes |
| 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 |
Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.
*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.
To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.