ANDA (Generic) Drug Approvals in 2016
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+ | |
|---|---|---|---|---|---|---|
| 73 | 207407 | Lopinavir and Ritonavir Oral Solution USP, 80 mg/ 20 mg per mL | Silarx Pharmaceuticals, Inc. | Kaletra (Lopinavir and Ritonavir) Oral Solution, 80 mg/ 20 mg per mL | 12/27/16 | For the treatment of HIV-1 infection in adults and pediatric patients (14 days and older) in combination with other antiretroviral agents |
| 72 | 206015 | Pitavastatin Calcium Tablets, 1 mg, 2 mg, 4 mg | Aurobindo Pharma Limited | Livalo (Pitavastatin Calcium) Tablets, 1 mg, 2 mg, 4 mg | 12/20/16 | As an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia or mixed dyslipidemia |
| 71 | 202842 | Dexmethylphenidate Hydrochloride Extended-Release Capsules, 25 mg, 35 mg | Par Pharmaceutical, Inc. | Focalin XR (Dexmethylphenidate Hydrochloride) Extended-Release Capsules, 25 mg, 35 mg | 11/30/16 | For treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older |
| 70 | 207231 | Iloperidone Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg | Inventia Healthcare Private Limited | Fanapt (Iloperidone) Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg | 11/28/16 | An atypical antipsychotic agent indicated for the treatment of schizophrenia in adults |
| 69 | 090681 | Quetiapine Fumarate Extended-Release Tablets, 400 mg | Accord Healthcare Inc. | Seroquel XR (Quetiapine Fumarate) Extended-Release Tablets, 400 mg | 11/1/2016 | For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; or major depressive disorder, adjunctive therapy with antidepressants |
| 68 | 203575 | Mycophenolate Mofetil Hydrochloride for Injection USP, 500 mg/ vial | Par Sterile Products LLC | Cellcept (Mycophenolate Mofetil Hydrochloride) for Injection, 500 mg/ vial | 10/28/2016 | For the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants |
| 67 | 078827 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, 40 mg/25 mg | Mylan Pharmaceuticals Inc. | Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, 40 mg/25 mg | 10/26/2016 | For the treatment of hypertension, to lower blood pressure |
| 66 | 078276 | Olmesartan Medoxomil Tablets, 5 mg, 20 mg, 40 mg | Mylan Pharmaceuticals Inc. | Benicar (Olmesartan Medoxomil) Tablets, 5 mg, 20 mg, 40 mg | 10/26/2016 | For the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure |
| 65 | 206137 | 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 mg | Par 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 mg | 10/26/2016 | For treatment of hypertension |
| 64 | 203580 | 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 mg | Torrent Pharmaceuticals Limited | 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 mg | 10/26/2016 | For treatment of hypertension |
| 63 | 206884 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg | Macleods Pharmaceuticals Limited | Azor (Amlodipine and Olmesartan Medoxomil) Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg | 10/26/2016 | For treatment of hypertension |
| 62 | 091154 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg | Teva Pharmaceuticals USA, Inc. | Azor (Amlodipine and Olmesartan Medoxomil) Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg | 10/26/2016 | For treatment of hypertension |
| 61 | 203594 | Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets, 3 mg/ 0.03 mg/ 0.451 mg and Levomefolate Calcium Tablets, 0.451 mg | Watson Laboratories, Inc | Safyral (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) Tablets, 3 mg/ 0.03 mg/ 0.451 mg, 0.451 mg | 10/11/2016 | For use by women to prevent pregnancy; to raise folate levels in women who choose to use an oral contraceptive |
| 60 | 203593 | Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets, 3 mg/ 0.02mg/ 0.451 mg and Levomefolate Calcium Tablets, 0.451 mg | Watson Laboratories, Inc. | Beyaz (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) Tablets, 3 mg/ 0.02mg/ 0.451 mg, 0.451 mg | 10/11/2016 | For 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 |
| 59 | 207366 | Ribavirin for Inhalation Solution USP, 6 g/vial | Navinta LLC | Virazole (Ribavirin) for Inhalation Solution, 6 g/vial | 10/6/2016 | For the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus |
| 58 | 204209 | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, 325 mg, 30 mg, 16 mg | Larken Laboratories, Inc. | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, 325 mg, 30 mg, 16 mg | 9/30/2016 | For the relief of moderate to moderately severe pain |
| 57 | 206028 | Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg | Lupin Limited | Namenda XR (Memantine Hydrochloride) Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg | 9/28/2016 | For the treatment of moderate to severe dementia of the Alzheimer’s type |
| 56 | 206032 | Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg | Mylan Pharmaceuticals Inc. | Namenda XR (Memantine Hydrochloride) Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg | 9/28/2016 | For the treatment of moderate to severe dementia of the Alzheimer’s type |
| 55 | 205905 | Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg | Sun Pharma Global FZE | Namenda XR (Memantine Hydrochloride) Extended-Release Capsules, 7 mg, 14 mg, 21 mg, 28 mg | 9/28/2016 | For the treatment of moderate to severe dementia of the Alzheimer’s type |
| 54 | 201107 | Abacavir Oral Solution USP, 20 mg / mL | Hetero Labs Limited Unit III | Ziagen (Abacavir) Oral Solution, 20 mg / mL | 9/26/2016 | In combination with other antiretroviral agents, for the treatment of HIV-1 infection |
| 53 | 205975 | Naftifine Hydrochloride Cream USP, 1% | Taro Pharmeceuticals USA, Inc. | Naftin (Naftifine Hydrochloride) Cream, 1% | 9/8/2016 | For topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum |
| 52 | 207133 | Flurandrenolide Lotion USP, 0.05% | Perrigo UK FINCO Limited Partnership | Cordran (Flurandrenolide) Lotion, 0.05% | 8/30/2016 | For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses |
| 51 | 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 |
| 50 | 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 |
| 49 | 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 |
| 48 | 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 |
| 47 | 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 |
| 46 | 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 |
| 45 | 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 |
| 44 | 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 |
| 43 | 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 |
| 42 | 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 |
| 41 | 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) |
| 40 | 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 |
| 39 | 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 |
| 38 | 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 |
| 37 | 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 |
| 36 | 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 |
| 35 | 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 |
| 34 | 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 |
| 33 | 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 |
| 32 | 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 |
| 31 | 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) |
| 30 | 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 |
| 29 | 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 |
| 28 | 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 |
| 27 | 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 |
| 26 | 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 |
| 25 | 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 |
| 24 | 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 |
| 23 | 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 |
| 22 | 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 |
| 21 | 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 |
| 20 | 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 |
| 19 | 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 |
| 18 | 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) |
| 17 | 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) |
| 16 | 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 |
| 15 | 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 |
| 14 | 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 |
| 13 | 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 |
| 12 | 205076 | Oxiconazole Nitrate Cream, 1% | Taro Pharmeceuticals USA, Inc. | Oxistat (Oxiconazole Nitrate) Cream, 1% | 3/7/2016 | Topical treatment of dermal infections |
| 11 | 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 |
| 10 | 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 |
| 9 | 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 |
| 8 | 204648 | Diclofenac Potassium Capsules, 25 mg | Bionpharma Inc. | Zipsor (Diclofenac Potassium) Capsules, 25 mg | 2/23/2016 | Relief of mild to moderate acute pain |
| 7 | 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 |
| 6 | 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 |
| 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.