2018 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 2018*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 99 | 210618 | Hydroxyprogesterone Caproate Injection USP, 1250 mg/5 mL (250 mg/mL) Multi-dose Vials | Slayback Pharma LLC mg/mL | Makena (Hydroxyprogesterone Caproate) Injection, 250 mg/mL | 12/28/2018 | For reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth |
| 98 | 209345 | Pimecrolimus Cream, 1% | Actavis Laboratories UT, Inc. | Elidel (Pimecrolimus) Cream, 1% | 12/27/2018 |
For the second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis |
| 97 | 208861 | Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg | Actavis Elizabeth LLC | Aptensio XR (Methylphenidate Hydrochloride) Extended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg | 12/13/2018 | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) |
| 96 | 208813 | Toremifene Citrate Tablets, 60 mg | EirGen Pharma Limited | Fareston (Toremifene Citrate) Tablets, 60 mg | 12/4/2018 | For the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors |
| 95 | 204246 | Ganirelix Acetate Injection, 250 mcg/ 0.5 mL, Single-Dose Prefilled Syringe | Sun Pharmaceutical Industries Ltd. | Ganirelix Acetate Injection, 250 mcg/ 0.5 mL, Single-Dose Prefilled Syringe | 11/30/2018 | For the inhibition of premature LH surges in women undergoing controlled ovarian hyper-stimulation |
| 94 | 202584 | Bismuth Subsalicylate Chewable Tablets, 262.4 mg, Metronidazole Tablets, 250 mg, Tetracycline Hydrochloride Capsules, 500 mg | Ailex Pharmaceuticals, LLC | Helidac (Bismuth Subsalicylate Chewable Tablets, 262.4 mg, Metronidazole Tablets, 250 mg, Tetracycline Hydrochloride Capsules, 500 mg | 11/30/2018 | For the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer) |
| 93 | 208678 | Colchicine Capsules, 0.6 mg | Par Pharmaceutical, Inc. | Mitigare (Colchicine) Capsules, 0.6 mg | 11/29/2018 | For the prophylaxis of gout flares in adults |
| 92 | 208129 | Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/ 20 mL, 200 mcg/ 50 mL, 400 mcg/ 100 mL (4 mcg/mL) Single-Dose Containers | Fresenius Kabi USA, LLC | Precedex (Dexmedetomidine Hydrochloride) in 0.9% Sodium Chloride Injection, 80 mcg/ 20 mL, 200 mcg/ 50 mL, 400 mcg/ 100 mL (4 mcg/mL) Single-Dose Containers | 11/29/2018 | For the sedation of non-intubated patients prior to and/or during surgical and other procedures |
| 91 | 209060 | Aminocaproic Acid Tablets USP, 500 mg, 1000 mg | Sunny Pharmtech Inc | Amicar (Aminocaproic Acid) Tablets, 500 mg, 1000 mg | 11/27/2018 | For enhancing hemostasis when fibrinolysis contributes to bleeding |
| 90 | 202142 | Oxycodone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg per 5 mL | Mikart, Inc. | Roxicet (Oxycodone Hydrochloride and Acetaminophen) Oral Solution, 5 mg/ 325 mg per 5 mL | 11/27/2018 | For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| 89 | 204937 | Buprenorphine Transdermal System, 5 mcg/hour, 10 mcg/hour, 15 mcg/hour, 20 mcg/hour | Watson Laboratories, Inc. | Butrans (Buprenorphine) Transdermal System, 5 mcg/hour, 10 mcg/hour, 15 mcg/hour, 20 mcg/hour | 11/20/2018 | For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
| 88 | 200480 | DycloPro (Dyclonine Hydrochloride) Topical Solution, 0.5%, 1% | Novocol, Inc. dba Septodont | Dyclone (Dyclonine Hydrochloride) Topical Solution, 0.5%, 1% | 11/20/2018 | For anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures |
| 87 | 208754 | Docosanol Cream, 10% (OTC) | Actavis Laboratories UT, Inc. | Abreva (Docosanol) Cream, 10% (OTC) | 11/19/2018 | For the treatment of cold sores/fever blisters on the face or lips; shortens healing time and duration of symptoms |
| 86 | 208724 | Azelaic Acid Gel, 15% | Tolmar, Inc | Finacea (Azelaic Acid) Gel , 15% | 11/19/2018 | For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea |
| 85 | 208011 | Azelaic Acid Gel, 15% | Actavis Laboratories UT, Inc. | Finacea (Azelaic Acid) Gel, 15% | 11/19/2018 | For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea |
| 84 | 204637 | Azelaic Acid Gel, 15% | Glenmark Pharmaceuticals SA | Finacea (Azelaic Acid) Gel, 15% | 11/19/2018 | For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea |
| 83 | 208324 | Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg | Alembic Pharmaceuticals Limited | Staxyn (Vardenafil Hydrochloride) Orally Disintegrating Tablets, 10 mg | 11/16/2018 | For the treatment of erectile dysfunction |
| 82 | 208453 | Abiraterone Acetate Tablets, 250 mg | Apotex, Inc. | Zytiga (Abiraterone Acetate) Tablets, 250 mg | 10/31/2018 | For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) |
| 81 | 208446 | Abiraterone Acetate Tablets, 250 mg | Mylan Pharmaceuticals, Inc | Zytiga (Abiraterone Acetate) Tablets, 250 mg | 10/31/2018 | For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) |
| 80 | 208432 | Abiraterone Acetate Tablets, 250 mg | Teva Pharmaceuticals USA, Inc. | Zytiga (Abiraterone Acetate) Tablets, 250 mg | 10/31/2018 | For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) |
| 79 | 208339 | Abiraterone Acetate Tablets, 250 mg | Hikma Pharmaceuticals LLC | Zytiga (Abiraterone Acetate) Tablets, 250 mg | 10/31/2018 | For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) |
| 78 | 209726 | Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/ 25 mg (OTC) | Amneal Pharmaceuticals Company GmbH | Aleve PM (Naproxen Sodium and Diphenhydramine Hydrochloride) Tablets, 220 mg/ 25 mg (OTC) | 10/23/2018 | For the relief of occassional sleeplessness when associated with minor aches and pains |
| 77 | 211259 | Clobazam Oral Suspension, 2.5 mg/mL | Mylan Pharmaceuticals Inc. | Onfi (Clobazam) Oral Suspension, 2.5 mg/mL | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 76 | 210569 | Clobazam Oral Suspension, 2.5 mg/mL | Upsher-Smith Laboratories, LLC | Onfi (Clobazam) Oral Suspension, 2.5 mg/mL | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 75 | 210039 | Clobazam Oral Suspension, 2.5 mg/mL | Amneal Pharmaceuticals LLC | Onfi (Clobazam) Oral Suspension, 2.5 mg/mL | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 74 | 209715 | Clobazam Oral Suspension, 2.5 mg/mL | West-Ward Pharmaceuticals International Limited | Onfi (Clobazam) Oral Suspension, 2.5 mg/mL | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 73 | 208819 | Clobazam Oral Suspension, 2.5 mg/mL | Bionpharma Inc. | Onfi (Clobazam) Oral Suspension, 2.5 mg/mL | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 72 | 211449 | Clobazam Tablets, 10 mg, 20 mg | Zydus Pharmaceuticals (USA), Inc. | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 71 | 209808 | Clobazam Tablets, 10 mg, 20 mg | Piramal Healthcare UK Limited | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 70 | 209795 | Clobazam Tablets, 10 mg, 20 mg | Hetero USA, Inc. | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 69 | 209718 | Clobazam Tablets, 10 mg, 20 mg | Amneal Pharmaceuticals Company GmbH | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 68 | 209687 | Clobazam Tablets, 10 mg, 20 mg | Upsher-Smith Laboratories, LLC | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 67 | 209440 | Clobazam Tablets, 10 mg, 20 mg | Taro Pharmaceuticals U.S.A. Inc. | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 66 | 209308 | Clobazam Tablets, 10 mg, 20 mg | Breckenridge Pharmaceutical, Inc. | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 65 | 208825 | Clobazam Tablets, 10 mg, 20 mg | Bionpharma Inc. | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 64 | 208785 | Clobazam Tablets, 10 mg, 20 mg | West-Ward Pharmaceuticals Internatonal Limited | Onfi (Clobazam) Tablets, 10 mg, 20 mg | 10/22/2018 | For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older |
| 63 | 209148 | Adapalene and Benzoyl Peroxide Gel, 0.3%/ 2.5% | Taro Pharmaceuticals USA, Inc | Epiduo Forte (Adapalene and Benzoyl Peroxide) Gel, 0.3%/ 2.5% | 10/17/2018 | For the topical treatment of acne vulgaris |
| 62 | 207891 | Omeprazole Delayed-Release Tablets, 20 mg | Sun Pharmaceutical Industries Limited | Omeprazole Delayed-Release Tablets, 20 mg | 10/12/2018 | For the treatment of frequent heartburn |
| 61 | 210574 | Cefixime Capsules, 400 mg | Alkem Laboratories Limited | Suprax (Cefixime) Capsules, 400 mg | 10/9/2018 | For treatment of adults and children six months and older with Urinary Tract Infections, Pharyngitis, Tonsillitis, Acute Exacerbations of Chronic Bronchitis, and Uncomplicated Gonorrhea (cervical/urethral) |
| 60 | 207141 | Noxivent (Nitric Oxide) Gas for Inhalation, 100 ppm and 800 ppm | Praxair Distribution, Inc. | INOmax (Nitric Oxide) Gas for Inhalation, 100 ppm and 800 ppm | 10/2/2018 | For improved oxygenation and to reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure |
| 59 | 210434 | Albendazole Tablets USP, 200 mg | Cipla Limited | Albenza (Albendazole) Tablets, 200 mg | 9/21/2018 | For treatment of parenchymal neurocysticercosis due to active lesion caused by larval forms of the pork tapeworm, Taenia solium |
| 58 | 210179 | Carmustine for Injection USP, 100 mg/vial | Navinta LLC. | BiCNU (Carmustine) for Injection, 100 mg/vial | 9/11/2018 | For palliative therapy in certain brain tumors, multiple myeloma, relapsed or refractory Hodgkin's and Non-Hodgkin's lymphoma |
| 57 | 208390 | Ticagrelor Tablets, 60 mg, 90 mg | Watson Laboratories, Inc. | Brilinta (Ticagrelor) Tablets, 60 mg, 90 mg | 9/4/2018 | For post-acute coronary syndrome (ACS) management |
| 56 | 203041 | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg | Aurobindo Pharma Limited | Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) Tablets, 600 mg/200 mg/300 mg | 9/4/2018 | For the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg |
| 55 | 208231 | Arsenic Trioxide Injection, 10 mg/10 mL (1 mg/mL) Single-dose vial | Fresenius Kabi USA, LLC | Trisenox (Arsenic Trioxide) Injection, 10 mg/10 mL (1 mg/mL) Single-dose vial | 8/312018 | For induction of remission and consolidation in certain patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy |
| 54 | 090165 | Aripiprazole Orally Disintegrating Tablets USP, 20 mg, 30 mg | Zydus Pharmaceuticals (USA), Inc. | Abilify (Aripiprazole) DISCMELT Orally Disintegrating Tablets, 20 mg, 30 mg | 8/28/2018 | For the treatment of Schizophrenia |
| 53 | 209721 | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100mg/150mg, 133mg/200mg, 167mg/250mg | Amneal Pharmaceuticals Company GmbH | Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 100mg/150mg, 133mg/200mg, 167mg/250mg | 8/22/2018 | For the treatment of HIV-1 infection in adults and patients weighing at least 17kg; in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk |
| 52 | 209408 | Cefepime for Injection USP, 100 grams | Samson Medical Technologies, L.L.C. | Maxipime (Cefepime) for Injection, 100 grams | 8/22/2018 | For treatment of infections caused by susceptible strains of microorganisms |
| 51 | 208532 | Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) Single-Dose Containers | Baxter Healthcare Corporation | Precedex (Dexmedetomidine Hydrochloride) in 0.9% Sodium Chloride Injection, 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) Single-Dose Containers. | 8/21/2018 | For sedation of non-intubated patients prior to and/or during surgical and other procedures |
| 50 | 090589 | Epinephrine Injection USP, 0.15 mg and 0.3 mg | Teva Pharmaceuticals USA, Inc. | EpiPen Jr/EpiPen (Epinephrine) Injection, 0.15 mg and 0.3 mg | 8/16/2018 | For the emergency treatment of allergic reactions including anaphylaxis |
| 49 | 206685 | Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day | Mylan Technologies, Inc | Minivelle (Estradiol) Transdermal System, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day | 8/15/2018 | For the treatment of moderate to severe vasomotor symptoms due to menopause; for prevention of postmenopausal osteoporosis |
| 48 | 200630 | Tadalafil Tablets USP, 20 mg | Mylan Pharmaceuticals Inc. | Adcirca (Tadalafil) Tablets, 20 mg | 8/3/2018 | For the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability |
| 47 | 203153 | TemsiroLimus Injection, 25 mg/ml Single Dose Vial | Accord Healthcare Inc. | Torisel (Temsirolimus) Injection, 25mg/ml | 7/30/2018 | For the treatment of advanced renal cell carcinoma |
| 46 | 209549 | Teriflunomide Tablets, 7 mg, 14 mg | Watson Laboratories, Inc. | Aubagio (Teriflunomide) Tablets, 7 mg, 14 mg | 7/27/2018 | For the treatment of patients with relapsing forms of multiple sclerosis |
| 45 | 202586 | Indium in 111 Oxyquinoline Solution, USP, 1 mCi/mL | Nordion (Canada), inc. | Indium in 111 Oxyquinoline Solution, 1 mCi/mL | 7/25/2018 | .For radiolabeling autologous leukocytes |
| 44 | 207630 | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2% / 0.5% PF | Aurobindo Pharma Limited | Cosopt (Dorzolamide Hydrochloride and Timolol Maleate) Ophthalmic Solution, 2% / 0.5% PF | 7/24/2018 | For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers |
| 43 | 209107 | Cetirizine Hydrochloride Capsules, 10 mg | Aurobindo Pharma Limited | Cetirizine Hydrochloride Capsules, 10 mg | 7/20/2018 | For temporary relief of these symptoms due to hay fever or other respiratory allergies: runny nose; itchy, watery eyes; sneezing; itching of the nose or throat |
| 42 | 206107 | Asenapine Sublingual Tablets, 5 mg, 10 mg | Sigmapharm Laboratories, LLC | Saphris (Asenapine) Sublingual Tablets, 5 mg, 10 mg | 7/17/2018 | For the treatment of bipolar I disorder, as an adjunctive treatment to lithium or valproate in adults |
| 41 | 209448 | Dextrose Injection, 10% | Fresenius Kabi USA, LLC | Dextrose Injection USP, 10% | 7/16/2018 | For the treatment of hypoglycemia |
| 40 | 204393 | Morphine Sulfate Injection USP, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials | Piramal Critical Care Limited | Infumorph (Morphine Sulfate) Injection, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials | 7/16/2018 | For the management of pain severe enough to require use of an opioid analgesic by intravenous administration and for which alternative treatments are not expected to be adequate; for the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function |
| 39 | 202190 | Colesevelam Hydrochloride for Oral Suspension, 1.875 g/packet, 3.75 g/packet | Glenmark Pharmaceuticals Limited | Welchol (Colesevelam Hydrochloride) for Oral Suspension, 1.875 g/packet, 3.75 g/packet | 7/16/2018 | To reduce elevated low-density lipoprotein cholesterol (LDL-C) in certain adults with primary hyperlipidemia as monotherapy and in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia |
| 38 | 208257 | Roflumilast Tablets, 500 mcg | Mylan Pharmaceuticals | Daliresp (Roflumilast) Tablets, 500 mcg | 7/13/2018 | To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| 37 | 207568 | Epinephrine Injection, 1 mg/mL | Luitpold Pharmaceuticals, Inc | Adrenalin (Epinephrine) Injection, 1 mg/mL | 7/6/2018 | For emergency treatment of allergic reactions, including anaphylaxis |
| 36 | 205457 | Budesonide Extended-Release Tablets, 9 mg |
Actavis Laboratories FL, Inc. | Uceris (Budesonide) Extended Release Tablets, 9 mg | 7/5/2018 | For the induction of remission in patients with active, mild to moderate ulcerative colitis |
| 35 | 91168 | Emtricitabine capsules, 200 mg | Cipla Limited | Emtriva (Emtricitabine) Capsules, 200 mg | 7/2/2018 | Treatment of HIV-1 infection, in combination with other antiretroviral agents |
| 34 | 210723 | Hydroxyprogesterone Caproate Injection USP, 250 mg/mL Single-dose Vials | Luitpold Pharmaceuticals, Inc. | Makena (Hydroxyprogesterone Caproate) Injection USP, 250 mg/mL Single-dose Vials | 6/21/2018 | To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth |
| 33 | 207607 | Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg | Mylan Technologies Inc. | Suboxone (Buprenorphine and Naloxone) Sublingual Film, 8 mg/2 mg and 12 mg/3 mg | 6/14/2018 | For the treatment of opioid dependence |
| 32 | 205806 | Buprenorphine and Naloxone Sublingual Film, 4 mg/1 mg and 12 mg/3 mg | Dr. Reddy's Laboratories SA | Suboxone (Buprenorphine and Naloxone) Sublingual Film, 4 mg/1 mg and 12 mg/3 mg | 6/14/2018 | For the treatment of opioid dependence |
| 31 | 205299 | Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg | Dr. Reddy's Laboratories SA | Suboxone (Buprenorphine and Naloxone) Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg | 6/14/2018 | For the treatment of opioid dependence |
| 30 | 206166 | Ropivacaine Hydrochloride Injection USP, 200 mg/100 mL (2 mg/mL), 500 mg/100 mL (5 mg/mL), 400 mg/200 mL (2 mg/mL), and 1,000 mg/200 mL (5 mg/mL) Infusion Bags | Inforlife SA | Naropin (Ropivacaine Hydrochloride) Injection USP, 200 mg/100 mL (2 mg/mL), 500 mg/100 mL (5 mg/mL), 400 mg/200 mL (2 mg/mL), and 1,000 mg/200 mL (5 mg/mL) Infusion Bags | 6/11/2018 | For the production of local or regional anesthesia for surgery and for acute pain management |
| 29 | 207107 | Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg / 250 mL (10 mg/mL) and 2,000 mg/100 mL (20 mg/mL) | Sagent Pharmaceuticals, Inc. | Brevibloc (Esmolol Hydrochloride in Sodium Chloride) Injection, 2,500 mg / 250 mL (10 mg/mL) and 2,000 mg/100 mL (20 mg/mL) |
6/8/2018 |
For the short-term treatment of control of ventricular rate in supraventricular tachycardia, including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia; control of perioperative tachycardia and hypertension
|
| 28 | 206608 | Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag | Mylan Pharmaceuticals | Brevibloc (Esmolol Hydrochloride in Sodium Chloride) Injection, 2,500 mg/250mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag | 6/8/2018 |
For the short-term treatment of control of ventricular rate in supraventricular tachycardia, including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia; control of perioperative tachycardia and hypertension
|
| 27 | 208683 | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75% |
Taro Pharmaceuticals U.S.A., Inc. | Onexto (Clindamycin Phosphate and Benzoyl Peroxide) gel, 1.2%/3.75% | 6/5/2018 | For the topical treatment of acne vulgaris in patients 12 years of age and older |
| 26 | 207329 | Oxybutynin Chloride Gel, 10% | Par Pharmaceutical, Inc. | Gelnique (Oxybutynin Chloride) Gel, 10% | 5/31/2018 | For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency |
| 25 | 090141 | Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg | Teva Pharmaceutical USA, Inc. | Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg | 5/22/2018 | For the treatment of erectile dysfunction (ED), signs and symptoms of benign prostatic hyperplasia (BPH), ED and the signs and symptoms of BPH (ED/BPH) |
| 24 | 206049 | Methylphenidate Hydrochloride for Extended-Release Oral Suspension, 300 mg/60 mL total volume, 600 mg/120 mL total volume, 750 mg/150 mL total volume, and 900 mg/180 mL total volume (5 mg/mL) | Actavis Laboratories FL, Inc. | QUILLIVANT XR® (Methylphenidate Hydrochloride) for Extended-Release Oral Suspension, 25 mg per 5 mL | 5/17/2018 | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) |
| 23 | 091600 | Colesevelam Hydrochloride Tablets, 625 mg | Impax Laboratories, Inc. | Welchol (Colesevelam Hydrochloride)Tablets, 625 mg | 5/16/2018 | To reduce elevated low-density lipoprotein cholesterol (LDL-C) in certain adults with primary hyperlipidemia as monotherapy and in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia |
| 22 | 209373 | Phytonadione Tablets USP, 5 mg | Amneal Pharmaceuticals Company GmbH | Mephyton (Phytonadione) Tablets, 5 mg | 5/11/2018 | For the treatment of anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives, hypoprothrombinemia secondary to antibacterial therapy, hypoprothrombinemia secondary to administration of salicylates, certain hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas |
| 21 | 209467 | Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials | Zydus Pharmaceuticals (USA), Inc. | Quelicin (Succinylcholine Chloride) Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials | 5/4/2018 | As an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation |
| 20 | 210334 | Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via | Cipla Limited | Phenylephrine Hydrochloride | 4/27/2018 | For increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia |
| 19 | 210333 | Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package | Cipla Limited | Vazculep (Phenylephrine Hydrochloride) Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package | 4/27/2018 | For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesi |
| 18 | 202159 | Hydromorphone Hydrochloride Injection USP, 2 mg/mL Single-Dose Vial | Eurohealth International Sarl | Dilaudid (Hydromorphone Hydrochloride) Injection USP, 2 mg/mL Single-Dose Vial | 4/27/2018 | For management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate |
| 17 | 208342 | Miglustat Capsules, 100 mg | Amerigen Pharmaceuticals Limited | Zavesca (Miglustat) Capsules, 100 mg | 4/17/2018 | For treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option |
| 16 | 210088 | Loratadine Chewable Tablets USP, 5 mg (OTC) | Sun Pharma Global FZE | Children’s Claritin (Loratadine) Chewable Tablets, 5 mg | 4/16/2018 | For seasonal allergic rhinitis and idiopathic urticaria |
| 15 | 208790 | Ertapenem for Injection, 1 gram (base)/ Single-dose vial | ACS DOBFAR SPA | Invanz (Ertapenem) for Injection, 1 gram (base)/ Single-dose vial | 4/16/2018 |
For the treatment of certain moderate to severe infections caused by susceptible bacteria
|
| 14 | 206133 | Everolimus Tablets, 0.25 mg, 0.5 mg, and 0.75 mg | West-Ward Pharmaceuticals International Limited | Zortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 m | 4/12/2018 | For organ rejection prophylaxis in renal transplant patients with low-moderate immunologic risk |
| 13 | 090308 | Clozapine Orally Disintegrating Tablets, 12.5 mg | Barr Laboratories Inc. | Fazaclo (Clozapine) Orally Disintegrating Tablets, 12.5 mg | 4/9/2018 | For use as an anti-psychotic |
| 12 | 204636 | Ropivacaine Hydrochloride Injection USP, 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles | Akorn Inc. | Naropin (Ropivacaine Hydrochloride Injection USP), 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles | 3/16/2018 | For local, regional anesthesia and acute pain management |
| 11 | 208915 | Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) | Cipla Limited | Sensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) | 3/8/2018 | For the treatment of Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy |
| 10 | 206125 | Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base) and 90 mg (base) | Aurobindo Pharma Limited | Sensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg | 3/8/2018 | For the treatment of Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy |
| 9 | 209594 | Baclofen Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials | Mylan Laboratories Limited | Gablofen (Baclofen) Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials | 3/6/2018 | For use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above |
| 8 | 208234 | Desflurane USP, Liquid for Inhalation | Shanghai Hengrui Pharmaceutical Co., Ltd. | Suprane (Desflurane USP), Liquid for Inhalation | 2/26/2018 | Indicated for general anesthesia |
| 7 | 207457 | Sumatriptan and Naproxen Tablets, 85 mg/500 mg | Aurobindo Pharma Limited | Treximet (Sumatriptan and Naproxen) Tablets, 85 mg/500 mg | 2/15/2018 | Indicated for the acute treatment of migraine with or without aura in adults |
| 6 | 207567 | Trientine Hydrochloride Capsules USP, 250 mg |
Watson Laboratories, Inc | Syprine (Trientine Hydrochloride) Capsules USP, 250 mg | 2/7/2018 | Indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Syprine should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects |
| 5 | 091612 | Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg | Teva Pharmaceuticals USA, Inc. | Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg | 1/26/2018 | For the treatment of HIV-1 infection; for the treatment of chronic hepatitis B |
| 4 | 090647 | Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg | Aurobindo Pharma Limited | Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg | 1/26/2018 | Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. Indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older |
| 3 | 210375 | Levocetirizine Dihydrochloride Tablets USP, 5 mg | Dr. Reddy’s Laboratories Limited | Xyzal (Levocetirizine Dihydrochloride Tablets USP, 5 mg) Allergy 24HR | 1/19/2018 | For temporary relief of these symptoms due to hay fever or other respiratory allergies: runny nose; itchy, watery eyes; sneezing; itching of the nose or throat |
| 2 | 206223 | Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial | Fresenius Kabi USA, LLC | Ultiva® Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial | 1/16/2018 | For intravenous administration as: an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting; as an analgesic component of monitored anesthesia care in adult patients |
| 1 | 209688 | Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg) | Paddock LLC | K-Tab (Potassium Chloride Extended-Release Tablets) USP, 10 MEQ (750 mg), 20 MEQ (1500 mg) | 1/12/2018 | For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patientes with hypokalemic periodic paralysis; for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop (digitalized patients or patients with significant cardiac arrhythmias |
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.