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 2020*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 42 | 211194 | Dextrose 5% and Sodium Chloride Injection 0.3% USP, 250 mL, 500 mL, and 1,000 mL Bags | Fresenius Kabi USA, LLC | Dextrose 5% and Sodium Chloride Injection 0.3% USP, 250 mL, 500 mL, and 1,000 mL Bags | 8/26/2020 | For the parental replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient |
| 41 | 210531 | Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg | Mylan Pharmaceuticals Inc. | Tecfidera (Dimethyl Fumarate) Delayed-Release Capsules, 120 mg and 240 mg | 8/17/2020 | For the treatment of patients with relapsing forms of multiple sclerosis |
| 40 | 205548 | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP | Dr. Reddy's Laboratories Limited | Ciprodex (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Otic Suspension | 8/10/2020 | For the treatment of infections caused by susceptible isolates of the designated microorganisms in: Acute Otitis Media (AOM) in pediatric patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa; and in Acute Otitis Externa (AOE) in pediatric, adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa |
| 39 | 211436 | Mifepristone Tablets, 300 mg | Teva Pharmaceuticals USA, Inc. | Korlym (Mifepristone) Tablets, 300 mg | 8/3/2020 | For the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery |
| 38 | 213734 | Metyrosine Capsules USP, 250 mg | Amneal EU, Limited | Demser (Metyrosine) Capsules, 250 mg | 7/24/2020 | For the treatment of pheochromocytoma for preoperative preparation of patients for surgery, management of patients when surgery is contraindicated, and chronic treatment of patients with malignant pheochromocytoma |
| 37 | 213374 | Deferasirox Oral Granules, 90 mg, 180 mg and 360 mg | Alkem Laboratories Limited | Jadenu Sprinkle (Deferasirox) Oral Granules, 90 mg, 180 mg and 360 mg | 7/14/2020 | For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older |
| 36 | 211421 | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | Sunrise Pharmaceutical, Inc. | Librax (Chlordiazepoxide Hydrochloride and Clidinium Bromide) Capsules, 5 mg/2.5 mg | 7/7/2020 | To control emotional and somatic factors in gastrointestinal disorders; as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome and acute enterocolitis |
| 35 | 213725 | Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 mg | Sun Pharmaceutical Industries Limited | Protonix (Pantoprazole) Sodium for Delayed-Release Oral Suspension, 40 mg | 6/30/2020 | For the short-term treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD), for the maintenance of healing of erosive esophagitis, for pathologicall hypersecretory conditions Including Zollinger-Ellison (ZE) Syndrome |
| 34 | 210924 | Methylphenidate Extended-Release Orally Disintegrating Tablets, 8.6 mg, 17.3 mg, and 25.9 mg | Actavis Elizabeth LLC | Cotempla (Methylphenidate) XR-ODT Extended-Release Orally Disentegrating Tablets, 8.6 mg, 17.3 mg, 25.9 mg | 6/19/2020 | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age |
| 33 | 211722 | Betamethasone Dipropionate Spray, 0.05% | Taro Pharmaceuticals Inc. | Sernivo (Betamethasone Dipropionate) Spray, 0.05% | 6/17/2020 | For the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older |
| 32 | 211464 | Halobetasol Propionate Lotion, 0.05% | Perrigo Israel Pharmaceuticals Limited | Ultravate (Halobetasol Propionate) Lotion, 0.05% | 6/3/2020 | For the topical treatment of plaque psoriasis in patients 18 years of age and older |
| 31 | 209487 | Meloxicam Capsules, 5 mg and 10 mg | Lupin Limited | Vivlodex (Meloxicam) Capsules, 5 mg, 10 mg | 6/1/2020 | For the management of osteoarthritis pain |
| 30 | 211891 | Tolvaptan Tablets, 15 mg, 30 mg, and 60 mg | Alkem Laboratories Limited | Samsca Tablets, 15 mg, 30 mg, and 60 mg | 5/19/2020 | For the treatment of clinically significant hypervolemic and euvolemic hyponatremia |
| 29 | 207605 | Tolvaptan Tablets, 15 mg and 30 mg | Apotex Inc. | Samsca Tablets, 15 mg and 30 mg | 5/19/2020 | For the treatment of clinically significant hypervolemic and euvolemic hyponatremia |
| 28 | 208773 | Posaconazole Oral Suspension, 200 mg/5 mL (40 mg/mL) | Hikma Pharmaceuticals USA, Inc | Noxafil (Posaconazole) Oral Suspension, 200 mg/5 mL (40 mg/mL) | 5/15/2020 | 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, and for the treatment of oropharyngeal candidiasis |
| 27 | 209457 | Icosapent Ethyl Capsules, 1 gram | Hikma Pharmaceuticals USA Inc | Vascepa (Icosapent Ethyl) Capsules, 1 gram | 5/15/2020 | Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia |
| 26 | 213038 | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg | Laurus Labs Limited | SYMFI LO (Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate) Tablets, 400 mg/300 mg/300 mg | 5/14/2020 | A complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg |
| 25 | 212786 | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg | Laurus Labs Limited | SYMFI (Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate) Tablets, 600 mg/300 mg/300 mg | 5/14/2020 | A complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg |
| 24 | 211571 | Esomeprazole Magnesium Delayed-Release Tablets, 20 mg (base) (OTC) | Dr. Reddy's Laboratories Limited | Nexium 24HR Delayed-Release Tablets (Esomeprazole Magnesium) Delayed-Release Tablets, 20 mg (base) (OTC) | 5/14/2020 | For the treatment of frequent heartburn (occurs 2 or more days a week) |
| 23 | 210765 | Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% | Tolmar, Inc. | Taclonex Topical Suspension, (Calcipotriene and Betamethasone) Topical Suspension, 0.005%/0.064% | 5/11/2020 | For the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older |
| 22 | 202470 | Desonide Gel, 0.05% | Teresina Holdings LLC | Desonate (Dseonide) Gel 0.05% | 5/11/2020 | For the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older |
| 21 | 205789 | Ursodiol Capsules USP, 200 mg, 400 mg. | Nexgen Pharma, Inc. | Actigall ( Ursidiol) Capsules USP, 200 mg., 400 mg. | 5/8/2020 | For the treatment and prevention of gallstones |
| 20 | 210720 | Ivermectin Lotion, 0.5% | Taro Pharmaceutical Industries Ltd. | Sklice (Ivermectin) Lotion, 0.5% | 5/6/2020 | For the topical treatment of head lice infestations in patients 6 months of age and older |
| 19 | 211880 | Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL, Multiple-Dose Vials | International Medication Systems, Limited | Adrenalin (Epinephrine) Injection USP, 30 mg/30 mL (1 mg/mL), Multiple-Dose Vials | 4/24/2020 | For the emergency treatment of allergic reactions (Type 1), including anaphylaxis; to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock |
| 18 | 206370 | Clocortolone Pivalate Cream USP, 0.1% | Taro Pharmaceuticals USA, Inc. | Cloderm (Clocortolone Pivalate) Cream USP, 0.1% | 4/21/2020 | For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses |
| 17 | 211586 | Buprenorphine Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, and 20 mcg/hr | Amneal Pharmaceuticals LLC | Butrans (Buprenorphine) Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, and 20 mcg/hr | 4/14/2020 | 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 |
| 16 | 209959 | Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation | Cipla Limited | Proventil HFA (Albuterol Sulfate) Inhalation Aerosol, 90 mcg (base)/actuation | 4/8/2020 | For the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in adults and children 4 years of age and older |
| 15 | 211752 | Esomeprazole Magnesium Delayed-Release for Oral Suspension, 10 mg | Cipla Limited | Nexium (Esomeprazole Magnesium) Delayed-Release for Oral Suspension, 10 mg | 3/23/2020 | For the treatment of gastroesophageal reflux disease, risk reduction of NSAID associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions |
| 14 | 211751 | Esomeprazole Magnesium Delayed-Release for Oral Suspension, 20 mg, 40 mg | Cipla Limited | Nexium (Esomeprazole Magnesium) Delayed-Release for Oral Suspension, 20 mg, 40 mg | 3/23/2020 | For the treatment of gastroesophageal reflux disease, risk reduction of NSAID associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions |
| 13 | 211185 | Carfilzomib for Injection, 30 mg Single-Dose Vial | Apotex Inc. | Kyprolis (Carfilzomib) for Injection, 30 mg Single-Dose Vial | 3/20/2020 | For the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy |
| 12 | 208040 |
Dabigatran Etexilate Capsules, 75 mg, 150 mg | Alkem Laboratories Limited. | Pradaxa (Dabigatran Etexilate) 75 mg, 150 mg | 3/11/2020 |
To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE); for the prophylaxis of DVT and PE in certain patients |
| 11 | 204962 | Prednisolone Sodium Phosphate Oral Solution, 30 mg/5 mL | Pharmaceutical Associates, Inc. | Orapred (Prednisolone Sodium Phosphate) Oral Solution, 30 mg/5 ml | 3/11/2020 | For the control of severe or incapacitating allergic conditions: seasonal or perennial allergic rhinitis; asthma, contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions |
| 10 | 209323 | Melphalan for Injection, 50 mg Single-Dose Vial |
Actavis LLC | Evomela (Melphalan) for Injection, 50 mg Single-Dose Vial | 3/6/2020 | For the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate |
| 9 | 213049 | Thiotepa for Injection USP, 15 mg/vial, 100 mg/vial Single-Dose Vials | MSN Laboratories Private Limited | Tepadina (Thiotepa) for Injection USP, 15 mg/vial, 100 mg/vial Single-Dose Vials | 3/4/2020 | For the treatment of adenocarcinoma of the breast or ovary; controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities; treating superficial papillary carcinoma of the urinary bladder |
| 8 | 211309 | Metformin Hydrochloride Oral Solution, 500 mg/5 mL | Saptalis Pharmaceuticals LLC | Riomet (Metformin Hydrochloride) Oral Solution, 500 mg/5 mL |
3/3/2020 | For improving glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus |
| 7 | 211393 |
Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) | Custopharm, Inc. | Migranal (Dihydroergotamine Mesylate) Nasal Spray, 4 mg/mL | 2/28/2020 | For the acute treatment of migraine headaches with or without aura |
| 6 | 207127 |
Pyrimethamine Tablets, 25 mg | Cerovene, Inc. | Daraprim (Pyrimethamine) Tablets, 25 mg | 2/26/2020 | For the treatment of toxoplasmosis when used conjointly with a sulfonamide |
| 5 | 203760 | Albuterol Sulfate Inhalation Aerosol, 90 mcg/actuation | Perrigo Pharmaceuticals Company | ProAir HFA (Albuterol Sulfate Inhalation Aerosol), 90 mcg/actuation | 2/24/2020 | For the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease; prevention of exercise-induced bronchospasm in patients 4 years of age and older |
| 4 | 208637 |
Solution USP, 0.7% |
Watson Laboratories, Inc. | Pazeo (Olopatadine Hydrochloride) Ophthalmic Solution. 0.7% | 2/19/2020 | For the treatment of ocular itching associated with allergic conjunctivitis |
| 3 | 204206 |
Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, 375 mg/20 mg and 500 mg/20 mg | Dr. Reddy's Laboratories Limited | Vimovo (Naproxen and Esomeprazole Magnesium)Delayed-Release Tablets,375 mg/20 mg and 500 mg/20 mg | 2/18/2020 | For the symptomatic relief of arthritis to decrease the risk of developing naproxen-associated gastric ulcers. |
| 2 | 209166 |
Sodium Iodide I 131 Solution USP and Sodium Iodide I 131 Capsules USP,1000 mCi/mL | International Isotopes, Inc. | Hicon (Sodium Iodide I 131) Solution and Capsules, 1000 mCi/mL, | 2/5/2020 | For the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid |
| 1 | 206986 | Hydrocodone Bitartrate Extended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg | Alvogen Malta Operations Ltd. | Zohydro ER (Hydrocodone Bitartrate Extended-Release) Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | 1/21/2020 | 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 |
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.