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 2017*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
53 209113 Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL   Nesher Pharmaceuticals (USA) LLC  Tamiflu (Oseltamivir Phosphate) for Oral Suspension, 6 mg (base)/mL 9/14/2017 For the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours, and prevention of the flu in patients one year of age and older
52 207563 Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial; 80 mg/8 mL and 160 mg/16 mL (10 mg/mL) Multi-Dose Vial (one-vial formulation) Ingenus Pharmaceuticals, LLC Docetaxel Injection, 20 mg/2 mL (10 mg/mL) Single-Dose Vial; 80 mg/8 mL and 160 mg/16 mL (10 mg/mL) Multi-Dose Vial (one-vial formulation) 8/31/2017 For treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer
 
51 203900 Tacrolimus Injection, 5 mg/mL, 1 mL Single-Dose Vial Hospira, Inc. Prograf (Tacrolimus) Injection, 5 mg/mL, 1 mL Single-Dose Vial 8/25/2017 For prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants
50 209784 Ephedrine Sulfate Injection USP, 50 mg/mL Single-Dose Vial Sandoz Inc. Akovaz (Ephedrine Sulfate) Injection USP, 50 mg/mL Single-Dose Vial 8/23/2017 For the treatment of clinically important hypotension occurring in the setting of anesthesia
49 207193 Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (OTC) Perrigo R&D Company Nexium 24HR (Esomeprazole Magnesium) Delayed-Release Capsules, 20 mg (OTC) 8/18/2017 For the treatment of frequent heartburn (occurs 2 or more days a week)
 
48 090978 Lanthanum Carbonate Chewable Tablets, 500 mg (base), 750 mg (base), 1000 mg (base) Natco Pharma Limited Fosrenol (Lanthanum Carbonate) Chewable Tablets, 500 mg (base), 750 mg (base), 1000 mg (base) 8/11/2017 To reduce serum phosphate in patients with end stage renal disease (ESRD)
47 207252 Docetaxel Injection USP, 160 mg/8 mL (20 mg/mL) Single-Dose Vial (one-vial formulation) Jiangsu Hengrui Medicine Co., Ltd. Taxotere (Docetaxel) Injection Concentrate, 160 mg/8 mL (20 mg/mL) Single-Dose Vial (one-vial formulation) 8/9/2017 For treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer
 
46 206961 Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) (single-dose vials)  Nexus Pharmaceuticals, Inc.  Isuprel (Isoproterenol Hydrochloride) Injection, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) (single-dose vials)  8/2/2017 For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy; serious episodes of heart block and Adams-Stokes attacks, congestive
heart failure,  cardiogenic shock, and other serious issues
45 209088 10% Calcium Chloride Injection USP, 1 gram/10 mL (100 mg/mL) single-dose vial  Luitpold Pharmaceuticals, Inc.  10% Calcium Chloride Injection, 1 gram/10 mL (100 mg/mL) single-dose vial  7/27/2017 For the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels
44 208092 Minoxidil Topical Aerosol, 5% (For Women)  Watson Laboratories, Inc.  Women's Rogaine (Minoxidil) Topical Aerosol, 5%  7/27/2017 To regrow hair on the top of the scalp
43 203286  Mesalamine Delayed-Release Tablets USP, 800 mg  Zydus Pharmaceuticals (USA) Inc. Asacol HD (Mesalamine) Delayed-Release Tablets USP, 800 mg 7/21/2017 For the treatment of moderately active ulcerative colitis in adults
42 207179  Sevelamer Carbonate Tablets, 800 mg  Aurobindo Pharma Limited Renvela (Sevelamer Carbonate) Tablets, 800 mg  7/17/2017 For the control of serum phosphorus in adults with chronic kidney disease on dialysis 
41 205927 Prasugrel Tablets, 5 mg, 10 mg Mylan Pharmaceuticals Effient (Prasugrel) Tablets, 5 mg, 10 mg 7/12/2017 A P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in certain patients with acute coronary syndrome who are to be managed with PCI
40 205781  Testosterone Topical Gel 1.62% (20.25 mg/ 1.25 g packet), 1.62% (40.5 mg/ 2.6 g packet)  Perrigo UK Finco Limited Partnership Androgel (Testosterone) Topical Gel 1.62% (20.25 mg/ 1.25 g packet), 1.62% (40.5 mg/ 2.6 g packet)  7/12/2017 For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
 
39 201751  Ultacan (Articaine Hydrochloride and Epinephrine) Injection, USP 4%/ 1:200,000 Hansamed, Inc. Septocaine (Articaine Hydrochloride and Epinephrine) Injection, 4%/ 1:200,000  7/11/2017  For local, infiltrative, or conductive anesthesia in both simple and complex dental procedures
 
38 204663 Phentermine Hydrochloride Orally Disintegrating Tablets,
15 mg, 30 mg,  37.5 mg
Zydus Pharmaceuticals (USA) Inc. Suprenza (Phentermine Hydrochloride) Orally Disintegrating Tablets, 15 mg, 30 mg, 37.5 mg  6/28/2017  
 
For use as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for certain patients
37 207139 Paroxetine Capsules, 7.5 mg Actavis Laboratories FL, Inc. Brisdelle (Paroxetine) Capsules, 7.5 mg 6/20/2017 For the treatment of moderate to severe vasomotor symptoms associated with menopause
36 208765 Doxycycline Hyclate Tablets USP, 75 mg, 150 mg Mayne Pharma, Inc. Acticlate (Doxycycline Hyclate) Tablets, 75 mg, 150 mg 6/14/2017 For treatment of rickettsial, sexually transmitted, respiratory tract, ophthalmic, and specific bacterial infections; anthrax, including inhalational anthrax (post-exposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy for acute intestinal amebiasis and severe acne; and prophylaxis of malaria
35 207624 Sevelamer Carbonate Powder for Oral Suspension, 0.8 g, 2.4 g Aurobindo Pharma Limited Renvela (Sevelamer Carbonate) Powder for Oral Suspension, 0.8 g, 2.4 g 6/13/2017  For the control of serum phosphorus in adults with chronic kidney disease on dialysis
34 090894 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg  Teva Pharmaceuticals USA Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 200 mg/300 mg 6/8/2017 For the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. For treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg
33 091640 Mesalamine Delayed-Release Tablets USP, 1.2 g Zydus Pharmaceuticals (USA) Inc. Lialda (Mesalamine) Delayed-Release Tablets USP, 1.2 g 6/5/2017  For the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis 
32 79019 Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg  Glenmark Pharmaceuticals Limited  Strattera (Atomoxetine) Capsules USP,10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 5/30/2017 For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
31 79016 Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg  Aurobindo Pharma Limited Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg  5/30/2017 For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
30 79022 Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Teva Pharmaceuticals USA Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 5/30/2017 For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
29 78983 Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Apotex, Inc. Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg  5/30/2017 For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
28 077337 Rosiglitazone Maleate and Metformin Hydrochloride Tablets, 1 mg (base)/500 mg Teva Pharmaceuticals Avandamet (Rosiglitazone Maleate and Metformin Hydrochloride) Tablets, 1 mg (base)/500 mg 5/19/2017 For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
27 204029 Moxifloxacin Hydrochloride in Sodium Chloride 0.8% Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags  Mylan Laboratories Limited Avelox (Moxifloxacin Hydrochloride in Sodium Chloride 0.8%) Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags  5/5/2017 For the treatment of infections caused by designated, susceptible bacteria
26 090681 Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial  Abon Pharmaceuticals, LLC Clolar (Clofarabine) Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial 5/9/2017 For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
25 206260 Quetiapine Fumarate Extended-Release Tablets, 150 mg, 200 mg, 300 mg Accord Healthcare Inc.  Seroquel XR (Quetiapine Fumarate) Extended-Release, 150 mg, 200 mg, 300 mg   5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
24 090482 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg   Pharmadax Inc. Seroquel XR (Quetiapine Fumarate) Extended-Release), 50 mg, 150 mg, 200 mg, 300 mg, 400 mg  5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
23 202939 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg   Par Pharmaceutical Inc. Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg 5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
22 205833 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg   IntelliPharmaCeutics Corp. Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg 5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
21 207712 Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 137mcg/50mcg  Apotex Inc. Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray, 137mcg/50mcg 4/28/2017 For treatment of allergic rhinitis
20  208218 Vigabatrin for Oral Solution USP, 500mg per packet  Par Pharmaceutical, Inc. Sabril (Vigabatrin) for Oral Solution USP, 500mg per packet  4/27/2017 For treatment in refractory complex partial seizures as adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments. For treatment of infantile spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss
19  201890 Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg Impax  Laboratories Inc.
 
Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 4/26/2017 For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments
18 202968 Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg Watson Laboratories, Inc. Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 4/26/2017 For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments
17 200909 Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg Dr. Reddys Laboratories International SA Vytorin (Ezetimibe and Simvastatin) Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 4/26/2017 For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments
16 206084 Ezetimibe and Atorvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg  Watson Laboratories, Inc. Liptruzet (Ezetimibe and Atorvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg 4/26/2017 For use to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia and to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments
15 204867 Prednisone Delayed-Release Tablets, 1mg, 2mg, 5mg Actavis Laboratories FL Inc Rayos (Prednisone) Delayed-Release Tablets, 1mg, 2mg, 5mg 4/25/2017 For use as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation. For the treatment of certain endocrine conditions. For palliation of certain neoplastic conditions
14 202294 Dexlansoprazole Delayed-Release Capsules, 60 mg Par Pharmaceutical Inc.    Dexilant (Dexlansoprazole Delayed-Release) Capsules, 60 mg 4/19/2017 For healing of all grades of erosive esophagitis, maintenance of healed EE and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD)
13 208258 Tazarotene Cream, 0.1% Taro Pharmaceuticals USA, Inc. Tazorac and Avage (Tazarotene) Cream, 0.1% 4/3/2017

For use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs

12 204726 Silodosin Capsules, 4 mg, 8 mg Sandoz Inc. Rapaflo (Silodosin) Capsules, 4 mg, 8 mg 3/31/2017 For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
11 205468 Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base)  Nostrum Laboratories, Inc.  Venlafaxine Hydrochloride ER tablet (Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base)) 3/24/2017 For treatment of major depressive disorder and social anxiety disorder  
10 207809 Melphalan Tablets USP, 2 mg Alvogen Malta Operations Ltd.  Alkeran (Melphalan) Tablets, 2 mg 3/22/2017 For palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary
204929 Zileuton Extended-Release Tablets, 600 mg  Pack Pharmaceuticals, LLC Zyflo CR (Zileuton) Extended-Release Tablets, 600 mg 3/17/2017 For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older  
202511 Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces Lupin Inc. Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate) Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces 2/23/2017 For cleansing of the colon in preparation for colonscopy in adults
7 207952 Logilia Ulipristal Acetate, 30 mg Teva Pharmaceuticals USA, Inc.  Ella (Ulipristal Acetate) Tablets, 30 mg  2/13/2017 For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
6 206939 Cefixime for Oral Suspension USP, 500 mg/5 mL Belcher Pharmaceuticals, LLC Suprax (Cefixime) for Oral Suspension, 500 mg/5 mL  2/6/2017 To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension
 5 208328 Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg Amneal Pharmaceuticals LLC Namzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg  1/27/2017 For the treatment of moderate to severe dementia of the Alzheimer’s type
4 206836 Dalfampridine Extended-Release Tablets, 10 mg Actavis Laboratories FL, Inc. Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg  1/23/2017 To improve walking in patients with multiple sclerosis (MS)
3 206811 Dalfampridine Extended-Release Tablets, 10 mg Aurobindo Pharma Limited Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg  1/23/2017 To improve walking in patients with multiple sclerosis (MS)
2  202090 Sodium Oxybate Oral Solution, 500 mg/mL Roxane Laboratories, Inc. Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL  1/17/2017 For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy
1  207160 Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL Aurobindo Pharma Limited Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL  1/4/2017 Antiepileptic drug indicated for adjunct therapy in adults (≥16 years of age) with certain seizure types when oral administration is temporarily not feasible

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.

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