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 NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
 72090681Quetiapine Fumarate Extended-Release Tablets, 400 mgAccord Healthcare Inc.Seroquel XR (Quetiapine Fumarate) Extended-Release Tablets,  400 mg11/1/2016For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; or major depressive disorder, adjunctive therapy with antidepressants
71203575Mycophenolate Mofetil Hydrochloride for Injection USP, 500 mg/ vialPar Sterile Products LLCCellcept (Mycophenolate Mofetil Hydrochloride) for Injection, 500 mg/ vial10/28/2016For the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants
70078827Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, 40 mg/25 mgMylan Pharmaceuticals Inc.Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, 40 mg/25 mg10/26/2016For the treatment of hypertension, to lower blood pressure
69078276Olmesartan Medoxomil Tablets, 5 mg, 20 mg, 40 mgMylan Pharmaceuticals Inc.Benicar (Olmesartan Medoxomil) Tablets, 5 mg, 20 mg, 40 mg10/26/2016For the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure
68206137Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mgPar Pharmaceutical, Inc.Tribenzor (Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide) Tablets, 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg10/26/2016For treatment of hypertension
67203580Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mgTorrent Pharmaceuticals LimitedTribenzor (Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide) Tablets, 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg10/26/2016For treatment of hypertension
66206884Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mgMacleods Pharmaceuticals LimitedAzor (Amlodipine and Olmesartan Medoxomil) Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg10/26/2016For treatment of hypertension
65091154Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mgTeva Pharmaceuticals USA, Inc.Azor (Amlodipine and Olmesartan Medoxomil) Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg10/26/2016For treatment of hypertension
64203594Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets, 3 mg/ 0.03 mg/ 0.451 mg and Levomefolate Calcium Tablets, 0.451 mgWatson Laboratories, IncSafyral (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) Tablets, 3 mg/ 0.03 mg/ 0.451 mg, 0.451 mg10/11/2016For use by women to prevent pregnancy; to raise folate levels in women who choose to use an oral contraceptive
63203593Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets, 3 mg/ 0.02mg/ 0.451 mg and Levomefolate Calcium Tablets, 0.451 mgWatson Laboratories, Inc.Beyaz (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) Tablets, 3 mg/ 0.02mg/ 0.451 mg, 0.451 mg10/11/2016For use by women to prevent pregnancy; to treat symptoms of premenstrual dysphoric disorder (PMDD), treat moderate acne or raise folate levels in women who choose to use an oral contraceptive
62207366Ribavirin for Inhalation Solution USP, 6 g/vialNavinta LLCVirazole (Ribavirin) for Inhalation Solution, 6 g/vial10/6/2016For the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus
61204209Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, 325 mg, 30 mg, 16 mgLarken Laboratories, Inc.Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, 325 mg, 30 mg, 16 mg9/30/2016For the relief of moderate to moderately severe pain
60206028Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mgLupin LimitedNamenda (Memantine Hydrochloride) Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg9/28/2016For the treatment of moderate to severe dementia of the Alzheimer’s type
59206032Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mgMylan Pharmaceuticals Inc.Namenda (Memantine Hydrochloride) Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg9/28/2016For the treatment of moderate to severe dementia of the Alzheimer’s type
58205905Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mgSun Pharma Global FZENamenda (Memantine Hydrochloride) Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg9/28/2016For the treatment of moderate to severe dementia of the Alzheimer’s type
57201107Abacavir Oral Solution USP, 20 mg / mLHetero Labs Limited Unit IIIZiagen (Abacavir) Oral Solution, 20 mg / mL9/26/2016In combination with other antiretroviral agents, for the treatment of HIV-1 infection
56205975Naftifine Hydrochloride Cream USP, 1%Taro Pharmeceuticals USA, Inc.Naftin (Naftifine Hydrochloride) Cream, 1%9/8/2016For topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum
55200264Fenofibric Acid Delayed Release Capsules, 45 mg, 135 mgImpax Laboratories Inc.Trilipix (Fenofibric Acid) Delayed Release Capsules, 45 mg, 135 mg9/7/2016A PPAR alpha agonist indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia, and to reduce elevated LDL-C, Total-C, TG and Apo B and increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia
54207133Flurandrenolide Lotion USP, 0.05%Perrigo UK FINCO Limited PartnershipCordran (Flurandrenolide) Lotion, 0.05%8/30/2016For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
53205811Doxylamine Succinate and Pyridoxine HCL Delayed Release Tablets, 10 mg/10 mgActavis Laboratories FL, Inc.Diclegis (Doxylamine Succinate and Pyridoxine HCL) Delayed Release Tablets, 10 mg/10 mg8/19/2016For treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
52202595Oseltamivir Phosphate Capsules USP, 30 mg, 45 mg, 75 mgNatco Pharma LimitedTamiflu (Oseltamivir Phosphate) Capsules, 30 mg, 45 mg, 75 mg8/3/2016For 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
51201509Zolpidem Tartrate Sublingual Tablets, 5 mg, 10 mgPar Formulations Private LimitedEdluar (Zolpidem Tartrate) Sublingual Tablets, 5 mg, 10 mg8/1/2016For the short-term treatment of insomnia characterized by difficulties with sleep initiation
50207631Nilutamide Tablets, 150 mgAni Pharmaceuticals, Inc.Nilandron (Nilutamide) Tablets, 150 mg 7/15/2016For use in combination with surgical castration for the treatment of metastatic prostate cancer
49205612Ropivcaine 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 LimitedNaropin (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% 7/13/2016For the production of local or regional anesthesia for surgery and for acute pain management
48202144Hydromorphone Extended-Release Tablets, 32 mgActavis Laboratories FL, Inc.Exalgo (Hydromophone) Extended-Release Tablets, 32 mg6/30/2016An 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
47205609Ethacrynic Acid Tablets USP, 25 mgEdenbridge Pharmaceuticals LLCEdecrin (Ethacrynic Acid) Tablets, 25 mg6/30/2016For 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
46206163Levothyroxine Sodium for Injection, 100 mcg/vial, 500 mcg/vialFera Phamaceuticals LLCLevothyroxine Sodium for Injection, 100 mcg/vial, 500 mcg/vial6/29/2016For the treatment of myxedema coma
45204475Fenofibrate Tablets USP, 40 mg, 120 mgMylan Pharmaceuticals Inc.Fenoglide (Fenofibrate) Tablets, 40 mg, 120 mg6/23/2016As an adjunct to diet, to treat adult patients with hypercholesterolemia, mixed dyslipidemia, or severe hypertriglyceridemia and to increase high-density lipoprotein
44206263Levoleucovorin for Injection, 50 mg/vialEurohealth International SarlFusilev (Levoleucovorin) for Injection, 50 mg/vial6/16/2016Folate 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
43202103Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 100 mgApotex, Inc.Sprycel (Dasatinib) Tablets, 20 mg, 50 mg, 70 mg, 100 mg6/10/2016For the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)
42206197Fosaprepitant Dimeglumine for Injection, 150 mg/vialFresenius Kabi USA, LLCEmend (Fosaprepitant Dimeglumine) for Injection, 150 mg/vial6/9/2016For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (HEC) in conjunction with other antiemtic agents
41207058Dofetalide Capsules, 0.125 mg, 0.25 mg, 0.5 mgTiger Pharmaceuticals Inc.Tikosyn (Dofetalide) Capsules, 0.125 mg, 0.25 mg, 0.5 mg6/6/2016For 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
40206287Mibelas 24 FE, 0.02 mg, 1 mgLupin Pharmaceuticals, Inc.Minastrin (Norethindrone Acetate and Ethinyl Estradiol & Ferrous Fumara) 24 FE Tablets, 0.02 mg; 1 mg5/24/2016For use by women to prevent pregnancy
39090431Doxycycline Hyclate Delayed-Release Tablets USP, 50 mgMylan Pharmaceuticals Inc.Doryx (Doxycycline Hyclate) Delayed-Release Tablets, 50 mg5/23/2016For 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
38205095Rufinamide Tablets USP, 200 mg, 400 mgMylan Pharmaceuticals Inc.Banzel (Rufinamide) Tablets, 200 mg, 400 mg5/16/2016For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in  patients 1 year of age and older
37205075Rufinamide Tablets USP, 200 mg, 400 mgGlenmark Pharmaceuticals LimitedBanzel (Rufinamide) Tablets, 200 mg, 400 mg5/16/2016For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in  patients 1 year of age and older
36204988Rufinamide Tablets USP, 200 mg, 400 mgRoxane Laboratories, Inc.Banzel (Rufinamide) Tablets, 200 mg, 400 mg5/16/2016For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in  patients 1 year of age and older
35202349Estradiol Valerate/ Estradiol Valerate/ Dienogest Tablets 1 mg and 3 mg/2/2 mg and 2/3 mgWatson Laboratories, Inc.Natazia (Estradiol Valerate/ Estradiol Valerate/ Dienogest)Tablets, 1 mg and 3 mg/2/2 mg and 2/3 mg5/6/2016For use by women to prevent pregnancy
34202964Diclofenac Potassium for Oral Solution, 50 mgPar Formulations Private LimitedCambia (Diclofenac Potassium) for Oral Solution, 50 mg5/2/2016For the acute treatment of migraine attacks with or without aura in adults
33079167Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg, 40 mgWatson Laboratories, Inc.Crestor (Rosuvastatin Calcium) Tablets, 5 mg, 10 mg, 20 mg, 40 mg4/29/2016As an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia; to treat homozygous familial hypercholesterolemia (HoFH)
32205031Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mgSun Pharma Global FZEVimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
31205026Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mgMylan Pharmaceuticals Inc.Vimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
30204994Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mgAurobindoVimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
29204974Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mgAlembic PharmaVimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
28204921Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mgMSN LaboratoriesVimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
27204855Lacosamide Tablets 50 mg, 100 mg, 150 mg, 200 mgActavis LaboratoriesVimpat (Lacosamide) Tablets, 50 mg, 100 mg, 150 mg, 200 mg4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
26204839Lacosamide Oral Solution, 10 mg/mLAmnealVimpat (Lacosamide) Oral Solution, 10 mg/mL4/28/2016As adjunctive therapy in patients 17 years and older with partial-onset seizures
25204060Fosamprenavir Calcium Tablets, 700 mgMylan Pharmaceuticals Inc.Lexiva (Fosamprenavir Calcium) Tablets, 700 mg4/15/2016In combination with other antiretroviral agents, for the treatment of HIV-1 infection
24205342Flurandrenolide Cream USP, 0.05%Teligent Pharma, Inc.Cordran (Flurandrenolide) Cream SP, 0.05%4/13/2016For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
23078709Rosiglitazone Maleate and Glimeperide Tablets, 4 mg/1 mg, 4 mg/2 mg, 4 mg/4gm, 8 mg/2 mg, 8 mg/8 mgTeva Pharmaceuticals USAAvandaryl (Rosiglitazone Maleate and Glimeperide) Tablets, 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg, 8 mg/8 mg4/1/2016As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes
22202402Ibuprofen Lysine Injection, 20 mg/2mL (10 mg/mL) SDVExela Pharma Sciences, LLCNeoprofen (Ibuprofen Lysine) Injection, 200 mg/2mL (10 mg/mL)3/30/2016To 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
21205943Levonorgestrel 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 mgLupin LimitedQuartette (Levonorgestrel and Ethinyl Estradiol) Tablets, 0.15 mg/0.02 mg, 0.15 mg/0.02 mg, 0.15 mg/0.03 mg3/29/2016Combination oral contraceptive (COC) for use by women to prevent pregnancy
20091039Daptomycin for Injection, 500 mg/vialTeva Pharmaceuticals USACubicin (Daptomycin) for Injection, 500 mg/vial3/24/2016Treatment of skin infections and certain blood stream infections
19205476Bendamustine Hydrochloride for Injection, 25 mg/vial, 100 mg/vial (Single Dose vial)Innopharma Licensing LLCTreanda (Bendamustine Hydrochloride) for Injection, 25 mg/vial, 100 mg/vial3/24/2016Treatment of patients with Chronic Lymphocytic Leukemia (CLL)
18204771Bendamustine Hydrochloride for Injection, 25 mg/vial, 100 mg/vial (Single Dose vial)Glenmark Pharmaceuticals LimitedTreanda (Bendamustine Hydrochloride) for Injection, 25 mg/vial, 100 mg/vial3/24/2016Treatment of patients with Chronic Lymphocytic Leukemia (CLL)
17091161Mometasone Furoate Nasal Spray, 50mcgApotex Corp.Nasonex (Mometasone Furoate) Nasal Spray, 50mcg3/22/2016Treatment 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
16208077Diclofenac Sodium Topical Gel, 1%Amneal PharmaceuticalsVoltaren (Diclofenac Sodium) Gel, 1%3/18/2016Relief of the pain of osteoarthritis of joints amenable to topical treatment
15206485Magnesium Sulfate in Water for Injection, 40 mg/ML, 80 mg/MLFresenius Kabi USA, LLCMagnesium Sulfate in Water for Injection, 40 mg/mL, 80 mg/mL3/15/2016For the prevention and control of seizures in preeclampsia and eclampsia, respectively
14077342Sildenafil Citrate Tablets, 25 mg (base), 50 mg (base), 100 mg (base)Teva Pharmaceuticals USA, Inc.Viagra (Sildenafil Citrate) Tablets, 25 mg, 50 mg, 100 mg3/9/2016Erectile dysfunction
13205076Oxiconazole Nitrate Cream, 1%Taro Pharmeceuticals USA, Inc.Oxistat (Oxiconazole Nitrate) Cream, 1%3/7/2016Topical treatment of dermal infections
12207349Magnesium Sulfate in 5% Dextrose Injection USP, 1g/100mLHQ Specialty Pharma Corp.Magnesium Sulfate in 5% Dextrose Injection, 1g/mL3/2/2016Prevention and control of seizures
11208150 Fluticasone Propionate Nasal Spray USP, 50 mcg/sprayApotex Corp.Flonase (Fluticasone Propionate) Nasal Spray, 50 mcg/spray2/29/2016 Relief of symptoms of hay fever and seasonal allergies
10207096 Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%Ailex Pharmaceutical PVT LTDAmmonul (Sodium Phenylacetate and Sodium Benzoate) Injection, 10%/10%2/24/2016 Adjunctive therapy for treatment of acute hyperammonemia and associated encephalopathy
9204648 Diclofenac Potassium Capsules, 25 mgBionpharma Inc.Zipsor (Diclofenac Potassium) Capsules, 25 mg2/23/2016 Relief of mild to moderate acute pain
8204841Sumatriptan Nasal Spray USP, 5 mg/spray 20 mgLannett Holdings, Inc.Imitrex (Sumatriptan) Nasal Spray, 5 mg/spray, 20 mg/spray2/19/2016Acute treatment of migraine with or without aura in adults
7091471Efavirenz Tablets USP, 600 mgMylan Pharmaceuticals LTDSustiva (Efavirenz) Tablets, 600 mg2/17/2016Treatment of human immunodeficiency virus type 1 infection
6205304Carbidopa Tablets, 25 mgEdenbridge Pharmaceuticals LLCLodosyn (Carbidopa) Tablets, 25 mg2/17/2016Treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism
5205071Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, 100 mgLiberty Pharma, Inc.Savella (Milnacipran Hydrochloride) Tablets, 12.5 mg, 25 mg, 50 mg, 100 mg1/27/2016Management of fibromyalgia
4203560Defarasirox Tablets for Oral Suspension, 125 mg, 250 mg, 500 mgActavis Elizabeth, LLCExjade (Deferarasirox) Tablets for Oral Suspension, 125 mg, 250 mg, 500 mg1/26/2016Treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
3091532Vancomycin Hydrochloride for Injection USP, 100g PBPSamson Medical Technoligies, LLCVancomycin Hydrochloride for Injection USP, 100g1/6/2016Treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci
2206901Naftifine Hydrochloride Cream USP, 2%Taro Pharmeceuticals USA, Inc.Naftin (Naftifine Hydrochloride) Cream, 2%1/6/2016Treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum
1204593Adapalene Topical Solution, 0.1%Call Inc. (DBA Rochester Pharmaceuticals)Differin (Adapalene) Topical Solution, 0.1%1/5/2016Topical 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: 11/15/2016
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