Drugs

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 2016*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
62  205811 Doxylamine Succinate and Pyridoxine HCL Delayed Release Tablets 10 mg/10 mg Actavis Laboratories FL, Inc. Diclegis (Doxylamine Succinate and Pyridoxine HCL) Delayed Release Tablets 10 mg/10 mg 8/19/2016 For treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
61  202657 Zolpidem Tartrate Sublingual Tablets, 5 mg, 10 mg Mylan Pharmaceuticals Inc. Edluar (Zolpidem Tartrate) Sublingual Tablets, 5 mg, 10 mg 8/8/2016 For the short-term treatment of insomnia characterized by difficulties with sleep initiation
60  202595 Oseltamivir Phosphate Capsules USP, 30 mg, 45 mg, 75 mg Natco Pharma Limited Tamiflu (Oseltamivir Phosphate) Capsules, 30 mg, 45 mg, 75 mg 8/3/2016 For treatment of uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours; for treatment of prophylaxis of influenza A and B in patients 1 year and older
59  201509 Zolpidem Tartrate Sublingual Tablets, 5 mg, 10 mg Par Formulations Private Limited Edluar (Zolpidem Tartrate) Sublingual Tablets, 5 mg, 10 mg 8/1/2016 For the short-term treatment of insomnia characterized by difficulties with sleep initiation
58  079172 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Glenmark Pharmaceuticals Limited Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
57  079171 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Sandoz, Inc. Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
56  079170 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Aurobindo Pharma Limited Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
55  079169 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Sun Pharma Global FZE Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
54 079168 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Par Pharmaceuticals, Inc. Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
53 079166 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Teva Pharmaceuticals USA Inc. Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
52 079161 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Mylan Pharmaceuticals Inc. Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
51 079145 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Apotex, Inc. Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg  7/19/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH) as adjunctive therapy or alone
50 207631 Nilutamide Tablets, 150 mg Ani Pharmaceuticals, Inc. Nilandron (Nilutamide) Tablets, 150 mg  7/15/2016 For use in combination with surgical castration for the treatment of metastatic prostate cancer
49 205612 Ropivcaine HCL Injection, 40 mg/20 mL - 0.2%, 200 mg/100 mL - 0.2%, 100 mg/20 mL - 0.5%, 150 mg/30 mL - 0.5%, 150 mg/20 mL - 0.75%, 100 mg/10 mL - 1%, 200 mg/20 mL - 1% Aurobindo Pharma Limited Naropin (Ropivacaine HCL) Injection, 40 mg/20 mL - 0.2%, 200 mg/100 mL - 0.2%, 100 mg/20 mL - 0.5%, 150 mg/30 mL - 0.5%, 150 mg/20 mL - 0.75%, 100 mg/10 mL - 1%, 200 mg/20 mL - 1%  7/13/2016 For the production of local or regional anesthesia for surgery and for acute pain management
48 202144 Hydromorphone Extended-Release Tablets, 32 mg Actavis Laboratories FL, Inc. Exalgo (Hydromophone) Extended-Release Tablets, 32 mg 6/30/2016 An opioid agonists indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time
47 205609 Ethacrynic Acid Tablets USP, 25 mg Edenbridge Pharmaceuticals LLC Edecrin (Ethacrynic Acid) Tablets, 25 mg 6/30/2016 For treatment of edema associated with congestive heart failure, cirrhosis of liver, renal disease, including nephrotic syndrome, when an agent with greater diuretic potential than those commonly employed is required or rapid onset of diuresis is desired, e.g., in acute pulmonary edema
46 206163 Levothyroxine Sodium for Injection, 100 mcg/vial, 500 mcg/vial Fera Phamaceuticals LLC Levothyroxine Sodium for Injection, 100 mcg/vial, 500 mcg/vial 6/29/2016 For the treatment of myxedema coma
45 204475 Fenofibrate Tablets USP, 40 mg, 120 mg Mylan Pharmaceuticals Inc. Fenoglide (Fenofibrate) Tablets, 40 mg, 120 mg 6/23/2016 As an adjunct to diet, to treat adult patients with hypercholesterolemia, mixed dyslipidemia, or severe hypertriglyceridemia and to increase high-density lipoprotein
44 206263 Levoleucovorin for Injection, 50 mg/vial Eurohealth International Sarl Fusilev (Levoleucovorin) for Injection, 50 mg/vial 6/16/2016 Folate analog used as resuce after high-dose methotrexate therapy in osteosarcoma;  diminishes  toxicity and counteracts methotrexate elimination effects and inadvertent overdosage of folic acid antagonist; used in combination chemotherapy with 5-fluorouracil in palliative treatment of patients with advanced metastatic colorectal cancer
43 202103 Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 100 mg Apotex, Inc. Sprycel (Dasatinib) Tablets, 20 mg, 50 mg, 70 mg, 100 mg 6/10/2016 For the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)
42 206197 Fosaprepitant Dimeglumine for Injection, 150 mg/vial Fresenius Kabi USA, LLC Emend (Fosaprepitant Dimeglumine) for Injection, 150 mg/vial 6/9/2016 For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (HEC) in conjunction with other antiemtic agents
41 207058 Dofetalide Capsules, 0.125 mg, 0.25 mg, 0.5 mg Tiger Pharmaceuticals Inc. Tikosyn (Dofetalide) Capsules, 0.125 mg, 0.25 mg, 0.5 mg 6/6/2016 For the maintenance of normal sinus rhythm in patients with atrial fibrillation/flutter of greater than 1 week duration who have been converted to normal sinus rhythm; reserved for those highly symptomatic
40 206287 Mibelas 24 FE, 0.02 mg, 1 mg Lupin Pharmaceuticals, Inc. Minastrin (Norethindrone Acetate and Ethinyl Estradiol & Ferrous Fumara) 24 FE Tablets, 0.02 mg; 1 mg 5/24/2016 For use by women to prevent pregnancy
39 090431 Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg Mylan Pharmaceuticals Inc. Doryx (Doxycycline Hyclate) Delayed-Release Tablets, 50 mg 5/23/2016 For treatment of certain infections including rickettsial, sexually transmitted, respiratory, specific bacterial, ophthalmic, anthrax (including post-exposure), and other infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria
38 205095 Rufinamide Tablets USP, 200 mg, 400 mg Mylan Pharmaceuticals Inc. Banzel (Rufinamide) Tablets, 200 mg, 400 mg 5/16/2016 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in  patients 1 year of age and older
37 205075 Rufinamide Tablets USP, 200 mg, 400 mg Glenmark Pharmaceuticals Limited Banzel (Rufinamide) Tablets, 200 mg, 400 mg 5/16/2016 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in  patients 1 year of age and older
36 204988 Rufinamide Tablets USP, 200 mg, 400 mg Roxane Laboratories, Inc. Banzel (Rufinamide) Tablets, 200 mg, 400 mg 5/16/2016 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in  patients 1 year of age and older
35 202349 Estradiol Valerate/ Estradiol Valerate/ Dienogest Tablets 1 mg and 3 mg/2/2 mg and 2/3 mg Watson Laboratories, Inc. Natazia (Estradiol Valerate/ Estradiol Valerate/ Dienogest)Tablets, 1 mg and 3 mg/2/2 mg and 2/3 mg 5/6/2016 For use by women to prevent pregnancy
34 202964 Diclofenac Potassium for Oral Solution, 50 mg Par Formulations Private Limited Cambia (Diclofenac Potassium) for Oral Solution, 50 mg 5/2/2016 For the acute treatment of migraine attacks with or without aura in adults
33 079167 Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mg Watson Laboratories, Inc. Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg 4/29/2016 As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH)
32 205031 Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mg Sun Pharma Global FZE Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
31 205026 Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mg Mylan Pharmaceuticals Inc. Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
30 204994 Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mg Aurobindo Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
29 204974 Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mg Alembic Pharma Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
28 204921 Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mg MSN Laboratories Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
27 204855 Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mg Actavis Laboratories Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
26 204839 Lacosamide Oral Solution, 10 mg/mL Amneal Vimpat (Lacosamide) Oral Solution, 10 mg/mL 4/28/2016 As adjunctive therapy in patients 17 years and older with partial-onset seizures
25 204060 Fosamprenavir Calcium Tablets, 700 mg Mylan Pharmaceuticals Inc. Lexiva (Fosamprenavir Calcium) Tablets, 700 mg 4/15/2016 In combination with other antiretroviral agents, for the treatment of HIV-1 infection
24 205342 Flurandrenolide Cream USP, 0.05% Teligent Pharma, Inc. Cordran (Flurandrenolide) Cream SP, 0.05% 4/13/2016 For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
23 078709 Rosiglitazone Maleate and Glimeperide Tablets, 4 mg/1 mg, 4 mg/2 mg, 4 mg/4gm, 8 mg/2 mg, 8 mg/8 mg Teva Pharmaceuticals USA Avandaryl (Rosiglitazone Maleate and Glimeperide) Tablets, 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg, 8 mg/8 mg 4/1/2016 As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes
22 202402 Ibuprofen Lysine Injection, 20 mg/2mL (10 mg/mL) SDV Exela Pharma Sciences, LLC Neoprofen (Ibuprofen Lysine) Injection, 200 mg/2mL (10 mg/mL) 3/30/2016 To close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age
21 205943 Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.02 mg, 0.15 mg/0.02 mg, 0.15 mg/0.03 mg; Ethinyl Estradiol Tablets USP, 0.01 mg Lupin Limited Quartette (Levonorgestrel and Ethinyl Estradiol) Tablets, 0.15 mg/0.02 mg, 0.15 mg/0.02 mg, 0.15 mg/0.03 mg 3/29/2016 Combination oral contraceptive (COC) for use by women to prevent pregnancy
20 091039 Daptomycin for Injection, 500 mg/vial Teva Pharmaceuticals USA Cubicin (Daptomycin) for Injection, 500 mg/vial 3/24/2016 Treatment of skin infections and certain blood stream infections
19 205476 Bendamustine Hydrochloride for Injection, 25 mg/vial, 100 mg/vial (Single Dose vial) Innopharma Licensing LLC Treanda (Bendamustine Hydrochloride) for Injection, 25 mg/vial, 100 mg/vial 3/24/2016 Treatment of patients with Chronic Lymphocytic Leukemia (CLL)
18 204771 Bendamustine Hydrochloride for Injection, 25 mg/vial, 100 mg/vial (Single Dose vial) Glenmark Pharmaceuticals Limited Treanda (Bendamustine Hydrochloride) for Injection, 25 mg/vial, 100 mg/vial 3/24/2016 Treatment of patients with Chronic Lymphocytic Leukemia (CLL)
17 091161 Mometasone Furoate Nasal Spray, 50mcg Apotex Corp. Nasonex (Mometasone Furoate) Nasal Spray, 50mcg 3/22/2016 Treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis in patients 2 years of age and older; prophylaxis for patients 12 years and older; treatment of nasal polyps in patients 18 years and older
16 208077 Diclofenac Sodium Topical Gel, 1% Amneal Pharmaceuticals Voltaren (Diclofenac Sodium) Gel, 1% 3/18/2016 Relief of the pain of osteoarthritis of joints amenable to topical treatment
15 206485 Magnesium Sulfate in Water for Injection, 40 mg/ML, 80 mg/ML Fresenius Kabi USA, LLC Magnesium Sulfate in Water for Injection, 40 mg/mL, 80 mg/mL 3/15/2016 For the prevention and control of seizures in preeclampsia and eclampsia, respectively
14 077342 Sildenafil Citrate Tablets, 25 mg (base), 50 mg (base), 100 mg (base) Teva Pharmaceuticals USA, Inc. Viagra (Sildenafil Citrate) Tablets, 25 mg, 50 mg, 100 mg 3/9/2016 Erectile dysfunction
13 205076 Oxiconazole Nitrate Cream, 1% Taro Pharmeceuticals USA, Inc. Oxistat (Oxiconazole Nitrate) Cream, 1% 3/7/2016 Topical treatment of dermal infections
12 207349 Magnesium Sulfate in 5% Dextrose Injection USP, 1g/100mL HQ Specialty Pharma Corp. Magnesium Sulfate in 5% Dextrose Injection, 1g/mL 3/2/2016 Prevention and control of seizures
11 208150  Fluticasone Propionate Nasal Spray USP, 50 mcg/spray Apotex Corp. Flonase (Fluticasone Propionate) Nasal Spray, 50 mcg/spray 2/29/2016  Relief of symptoms of hay fever and seasonal allergies
10 207096  Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% Ailex Pharmaceutical PVT LTD Ammonul (Sodium Phenylacetate and Sodium Benzoate) Injection, 10%/10% 2/24/2016  Adjunctive therapy for treatment of acute hyperammonemia and associated encephalopathy
9 204648  Diclofenac Potassium Capsules, 25 mg Bionpharma Inc. Zipsor (Diclofenac Potassium) Capsules, 25 mg 2/23/2016  Relief of mild to moderate acute pain
8 204841 Sumatriptan Nasal Spray USP, 5 mg/spray 20 mg Lannett Holdings, Inc. Imitrex (Sumatriptan) Nasal Spray, 5 mg/spray, 20 mg/spray 2/19/2016 Acute treatment of migraine with or without aura in adults
7 091471 Efavirenz Tablets USP, 600 mg Mylan Pharmaceuticals LTD Sustiva (Efavirenz) Tablets, 600 mg 2/17/2016 Treatment of human immunodeficiency virus type 1 infection
6 205304 Carbidopa Tablets, 25 mg Edenbridge Pharmaceuticals LLC Lodosyn (Carbidopa) Tablets, 25 mg 2/17/2016 Treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism
5 205071 Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, 100 mg Liberty Pharma, Inc. Savella (Milnacipran Hydrochloride) Tablets, 12.5 mg, 25 mg, 50 mg, 100 mg 1/27/2016 Management of fibromyalgia
4 203560 Defarasirox Tablets for Oral Suspension, 125 mg, 250 mg, 500 mg Actavis Elizabeth, LLC Exjade (Deferarasirox) Tablets for Oral Suspension, 125 mg, 250 mg, 500 mg 1/26/2016 Treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
3 091532 Vancomycin Hydrochloride for Injection USP, 100g PBP Samson Medical Technoligies, LLC Vancomycin Hydrochloride for Injection USP, 100g 1/6/2016 Treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci
2 206901 Naftifine Hydrochloride Cream USP, 2% Taro Pharmeceuticals USA, Inc. Naftin (Naftifine Hydrochloride) Cream, 2% 1/6/2016 Treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum
1 204593 Adapalene Topical Solution, 0.1% Call Inc. (DBA Rochester Pharmaceuticals) Differin (Adapalene) Topical Solution, 0.1% 1/5/2016 Topical application in the treatment of Acne Vulgaris

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.

Page Last Updated: 09/01/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.