Drugs

2017 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 NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
80 208788Estradiol Vaginal Cream USP, 0.01%Mylan Pharmaceuticals Inc.Estrace (Estradiol) Vaginal Cream, USP, 0.01% 12/29/2017Indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
79 207313 Butalbital and Acetaminophen Capsules, 50 mg/300 mgMikart, Inc.Phrenilin Forte (Butalbital and Acetaminophen) Capsules, 50 mg/650 mg12/27/2017Indicated for the relief of the symptom complex of tension (or muscle contraction) headache
78 078064 Efavirenz Capsules USP, 50 mg, 100 mg, and 200 mg Aurobindo Pharma Limited Sustiva Capsules (Efavirenz Capsules), 50 mg, 100 mg, and 200 mg 12/15/2017Indicated for the treatment of HIV-1 infection
77 207550 Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL vials, 200 mg/5 mL (40 mg/mL) Multi-dose vials and 400 mg/10 mL (40 mg/mL) Multi-dose vialsAmneal Pharmaceuticals Company GmbHKenalog (Triamcinolone Acetonide)-40 Injection, USP, 40 mg/mL vials, 200 mg/5 mL (40 mg/mL) Multi-dose vials and 400 mg/10 mL (40 mg/mL) Multi-dose vials12/13/2017For use as an injectable corticosteroid therapy
76 208518Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets, 10 mg/10 mg Par Pharmaceutical, Inc. Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride) Delayed-Release Tablets, 10 mg/10 mg12/6/2017Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management 
75 209235Ibuprofen and Pseudoephedrine Hydrochloride Capsules, 200 mg/ 30 mg (OTC) Aurobindo Pharma Limited Advil Cold and Sinus (Ibuprofen and Pseudoephedrine Hydrochloride) Liqu-Gels, 200 mg/ 30 mg (OTC)12/1/2017Indicated for the temporary relieve of symptoms associated with the common cold and flu
74 209102Baclofen Tablets USP, 5 mgRubicon Research Private LimitedLioresal (Baclofen)Tablets, 5 mg11/28/2017Indicated for use in the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity
73 208820 Praziquantel Tablets USP, 600 mg Par Pharmaceutical, Inc.Biltricide (Praziquantel) Tablets, 600 mg11/27/2017Indicated for the treatment of infections due to: all species of Schistosoma and infections due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini
72 202634Capreomycin for Injection USP, 1 gram per vialMylan Laboratories LimitedCapastat Sulfate (Capreomycin) for Injection, 1 gram/vial11/27/2017Indicated to be used concomitantly with other appropriate antituberculosis agents, in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli. Susceptibility studies should be performed to determine the presence of a capreomycin susceptible strain of M. tuberculosis
71 207382 Topiramate Extended-Release Capsules, 25 mg, 50 mg, and 100 mgZydus Pharmaceuticals (USA), IncTrokendi (Topiramate) XR Extended-Release Capsules11/24/2017For the treatment of: monotherapy epilepsy: initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy epilepsy: adjunctive therapy in patients 6 years of age and older with partial onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome; migraine: prophylaxis of migraine headache in adults and adolescents 12 years of age and older
70 209556 Hydrocortisone Butyrate Lotion, 0.1% Teligent Pharma, Inc.
 
Locoid (Hydrocortisone Butyrate) Lotion, 0.1%11/21/2017Indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older
69 202118Darunavir Tablets, 600 mg Teva Pharmaceuticals USA, Inc.Prezista (Darunavir) Tablets, 600 mg11/21/2017Indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older
68 209695Fluoxetine Tablets USP, 60 mgInventia Healthcare Private LimitedFluoxetine Tablets, 60 mg11/20/2017Indicated for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD), bulimia nervosa, and panic disorder, with or without agoraphobia
67 207338Fentanyl Sublingual Tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcgActavis Laboratories FL, Inc.Abstral (Fentanyl) Sublingual Tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg11/17/2017For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and
who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain
66 209419 Fluoxetine Tablets USP, 60 mgPar Pharmaceuticals, Inc.Fluoxetine Tablets, 60 mg11/16/2017Indicated for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD), bulimia nervosa, and panic disorder, with or without agoraphobia
65 205181Butenafine Hydrochloride Cream, 1%Taro Pharmaceuticals USA Inc.Lotrimin (Butenafine Hydrochloride) Ultra Cream, 1%11/16/2017Indicated for the treatment of Athlete’s Foot and Jock Itch
64 206687Sodium Acetate Injection USP, 400 mEq/100 mL (4 mEq/mL)Fresenius Kabi USA, LLCSodium Acetate Injection USP, 400 mEq/100 mL (4 mEq/mL) 10/30/2017Indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions
63 208306Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) multiple dose vialAkorn, Inc.Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) multiple dose vial 10/27/2017For the management of pain severe enough to require an opioid analgesic and for which alternative treatment options are inadequate; for use in temporary treatment of opioid dependence in patients unable to take oral medication
62 090132Carvedilol Phosphate Extended-Release Capsules, 10 mg, 20 mg, 40 mg and 80 mg


Sun Pharmaceutical Industries Inc.

Coreg CR (Carvedilol Phosphate) Extended-Release Capsules, 10 mg, 20
mg, 40 mg and 80 mg
10/25/2017Indicated for the treatment of hypertension
61 209662Potassium Chloride for Oral Solution USP, 20 mEq Upsher-Smith Laboratories, Inc.Klor-Con® Powder (Potassium Chloride for Oral Solution USP) , 20 mEq10/23/2017For treatment of potassium deficiency
60 209506Dapsone Gel, 5% Taro Pharmaceuticals USA Inc.Aczone (Dapsone) Gel, 5% 10/16/2017For the topical treatment of acne vulgaris 
59 202934Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules, 10 mg/20 mg Actavis Elizabeth LLC Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate) Capsules, 10 mg/20 mg 10/10/2017Indicated for the treatment of pseudobulbar affect (PBA)
58 206936 Glatiramer Acetate Injection, 40 mg/mlMylan Pharmaceuticals Inc.Copaxone (Glatiramer Acetate) Injection, 40 mg/ml10/3/2017Indicated for the treatment of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis         
57  207650Caspofungin Acetate for Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose VialsMylan Laboratories LimitedCancidas (Caspofungin Acetate) Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose Vials 9/29/2017For treatment in adults and pediatric patients (3 months of age and older) for: empirical therapy for presumed fungal infections in febrile, neutropenic patients, treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections, treatment of esophageal candidiasis, or the treatment of invasive aspergillosis in patients wo are refractory to or intolerant of other therapies
56 207092 Caspofungin Acetate for Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose VialsGland Pharma Limited Cancidas (Caspofungin Acetate) Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose Vials9/29/2017For treatment in adults and pediatric patients (3 months of age and older) for: empirical therapy for presumed fungal infections in febrile, neutropenic patients, treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections, treatment of esophageal candidiasis, or the treatment of invasive aspergillosis in patients wo are refractory to or intolerant of other therapies
55 204398Pilocarpine Hydrochloride Ophthalmic Solution USP, 1%, 2% and 4%Akorn Inc. Isopto Carpine (Pilocarpine Hydrochloride) Ophthalmic Solution USP, 1%, 2% and 4%9/27/2017For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, the management of acute angle-closure glaucoma, the prevention of postoperative elevated IOP associated with laser surgery,  or the induction of miosis
54 091073Testosterone Gel, 1%Actavis Laboratories UT, Inc. Testim (Testosterone) Gel, 1%9/18/2017For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
53209113Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL  Nesher Pharmaceuticals (USA) LLC Tamiflu (Oseltamivir Phosphate) for Oral Suspension, 6 mg (base)/mL9/14/2017For 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
52207563Docetaxel 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, LLCDocetaxel 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)8/31/2017For treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer
 
51203900Tacrolimus Injection, 5 mg/mL, 1 mL Single-Dose VialHospira, Inc.Prograf (Tacrolimus) Injection, 5 mg/mL, 1 mL Single-Dose Vial8/25/2017For prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants
50209784Ephedrine Sulfate Injection USP, 50 mg/mL Single-Dose VialSandoz Inc.Akovaz (Ephedrine Sulfate) Injection USP, 50 mg/mL Single-Dose Vial8/23/2017For the treatment of clinically important hypotension occurring in the setting of anesthesia
49207193Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (OTC)Perrigo R&D CompanyNexium 24HR (Esomeprazole Magnesium) Delayed-Release Capsules, 20 mg (OTC)8/18/2017For the treatment of frequent heartburn (occurs 2 or more days a week)
 
48090978Lanthanum Carbonate Chewable Tablets, 500 mg (base), 750 mg (base), 1000 mg (base)Natco Pharma LimitedFosrenol (Lanthanum Carbonate) Chewable Tablets, 500 mg (base), 750 mg (base), 1000 mg (base)8/11/2017To reduce serum phosphate in patients with end stage renal disease (ESRD)
47207252Docetaxel 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)8/9/2017For treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer
 
46206961Isoproterenol 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) 8/2/2017For 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
4520908810% 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 7/27/2017For the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels
44208092Minoxidil Topical Aerosol, 5% (For Women) Watson Laboratories, Inc. Women's Rogaine (Minoxidil) Topical Aerosol, 5% 7/27/2017To regrow hair on the top of the scalp
43203286 Mesalamine Delayed-Release Tablets USP, 800 mg Zydus Pharmaceuticals (USA) Inc.Asacol HD (Mesalamine) Delayed-Release Tablets USP, 800 mg7/21/2017For the treatment of moderately active ulcerative colitis in adults
42207179 Sevelamer Carbonate Tablets, 800 mg Aurobindo Pharma LimitedRenvela (Sevelamer Carbonate) Tablets, 800 mg 7/17/2017For the control of serum phosphorus in adults with chronic kidney disease on dialysis 
41205927Prasugrel Tablets, 5 mg, 10 mgMylan PharmaceuticalsEffient (Prasugrel) Tablets, 5 mg, 10 mg7/12/2017A 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
40205781 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 PartnershipAndrogel (Testosterone) Topical Gel 1.62% (20.25 mg/ 1.25 g packet), 1.62% (40.5 mg/ 2.6 g packet) 7/12/2017For 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)
 
39201751 Ultacan (Articaine Hydrochloride and Epinephrine) Injection, USP 4%/ 1:200,000Hansamed, 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
 
38204663Phentermine 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
37207139Paroxetine Capsules, 7.5 mgActavis Laboratories FL, Inc.Brisdelle (Paroxetine) Capsules, 7.5 mg6/20/2017For the treatment of moderate to severe vasomotor symptoms associated with menopause
36208765Doxycycline Hyclate Tablets USP, 75 mg, 150 mgMayne Pharma, Inc.Acticlate (Doxycycline Hyclate) Tablets, 75 mg, 150 mg6/14/2017For 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
35207624Sevelamer Carbonate Powder for Oral Suspension, 0.8 g, 2.4 gAurobindo Pharma LimitedRenvela (Sevelamer Carbonate) Powder for Oral Suspension, 0.8 g, 2.4 g6/13/2017 For the control of serum phosphorus in adults with chronic kidney disease on dialysis
34090894Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg Teva Pharmaceuticals USATruvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 200 mg/300 mg6/8/2017For 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
33091640Mesalamine Delayed-Release Tablets USP, 1.2 gZydus Pharmaceuticals (USA) Inc.Lialda (Mesalamine) Delayed-Release Tablets USP, 1.2 g6/5/2017 For the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis 
3279019Atomoxetine 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 mg5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
3179016Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Aurobindo Pharma LimitedStrattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
3079022Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mgTeva Pharmaceuticals USAStrattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
2978983Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mgApotex, Inc.Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
28077337Rosiglitazone Maleate and Metformin Hydrochloride Tablets, 1 mg (base)/500 mgTeva PharmaceuticalsAvandamet (Rosiglitazone Maleate and Metformin Hydrochloride) Tablets, 1 mg (base)/500 mg5/19/2017For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
27204029Moxifloxacin Hydrochloride in Sodium Chloride 0.8% Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags Mylan Laboratories LimitedAvelox (Moxifloxacin Hydrochloride in Sodium Chloride 0.8%) Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags 5/5/2017For the treatment of infections caused by designated, susceptible bacteria
26090681Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial Abon Pharmaceuticals, LLCClolar (Clofarabine) Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial5/9/2017For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
25206260Quetiapine Fumarate Extended-Release Tablets, 150 mg, 200 mg, 300 mgAccord Healthcare Inc. Seroquel XR (Quetiapine Fumarate) Extended-Release, 150 mg, 200 mg, 300 mg  5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
24090482Quetiapine 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 5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
23202939Quetiapine 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 mg5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
22205833Quetiapine 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 mg5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
21207712Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 137mcg/50mcg Apotex Inc.Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray, 137mcg/50mcg4/28/2017For treatment of allergic rhinitis
20 208218Vigabatrin for Oral Solution USP, 500mg per packet Par Pharmaceutical, Inc.Sabril (Vigabatrin) for Oral Solution USP, 500mg per packet 4/27/2017For 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 201890Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mgImpax  Laboratories Inc.
 
Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg4/26/2017For 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
18202968Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mgWatson Laboratories, Inc.Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg4/26/2017For 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
17200909Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mgDr. Reddys Laboratories International SAVytorin (Ezetimibe and Simvastatin) Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg4/26/2017For 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
16206084Ezetimibe 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 mg4/26/2017For 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
15204867Prednisone Delayed-Release Tablets, 1mg, 2mg, 5mgActavis Laboratories FL IncRayos (Prednisone) Delayed-Release Tablets, 1mg, 2mg, 5mg4/25/2017For 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
14202294Dexlansoprazole Delayed-Release Capsules, 60 mgPar Pharmaceutical Inc.   Dexilant (Dexlansoprazole Delayed-Release) Capsules, 60 mg4/19/2017For 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)
13208258Tazarotene 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

12204726Silodosin Capsules, 4 mg, 8 mgSandoz Inc.Rapaflo (Silodosin) Capsules, 4 mg, 8 mg3/31/2017For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
11205468Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base) Nostrum Laboratories, Inc. Venlafaxine Hydrochloride ER tablet (Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base))3/24/2017For treatment of major depressive disorder and social anxiety disorder  
10207809Melphalan Tablets USP, 2 mgAlvogen Malta Operations Ltd. Alkeran (Melphalan) Tablets, 2 mg3/22/2017For palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary
204929Zileuton Extended-Release Tablets, 600 mg Pack Pharmaceuticals, LLCZyflo CR (Zileuton) Extended-Release Tablets, 600 mg3/17/2017For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older  
202511Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ouncesLupin 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 ounces2/23/2017For cleansing of the colon in preparation for colonscopy in adults
7207952Logilia Ulipristal Acetate, 30 mgTeva Pharmaceuticals USA, Inc. Ella (Ulipristal Acetate) Tablets, 30 mg 2/13/2017For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
6206939Cefixime for Oral Suspension USP, 500 mg/5 mLBelcher Pharmaceuticals, LLCSuprax (Cefixime) for Oral Suspension, 500 mg/5 mL 2/6/2017To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension
 5208328Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mgAmneal Pharmaceuticals LLCNamzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg 1/27/2017For the treatment of moderate to severe dementia of the Alzheimer’s type
4206836Dalfampridine Extended-Release Tablets, 10 mgActavis Laboratories FL, Inc.Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg 1/23/2017To improve walking in patients with multiple sclerosis (MS)
3206811Dalfampridine Extended-Release Tablets, 10 mgAurobindo Pharma LimitedAmpyra (Dalfampridine) Extended-Release Tablets, 10 mg 1/23/2017To improve walking in patients with multiple sclerosis (MS)
2 202090Sodium Oxybate Oral Solution, 500 mg/mLRoxane Laboratories, Inc.Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL 1/17/2017For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy
1 207160Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mLAurobindo Pharma LimitedLevetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL 1/4/2017Antiepileptic 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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