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 2019*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 108 | 209446 | Mirabegron Extended-Release Tablets, 25 mg | Sawai USA, Inc. | Myrbetriq (Mirabegron) Extended-Release Tablets, 25 mg | 12/27/2019 | For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| 107 | 211908 | Ziprasidone Mesylate for Injection, 20 mg (base)/mL Single-dose Vials | Gland Pharma Limited | Geodon (Ziprasidone Mesylate) for Injection, 20 mg (base)/mL Single-dose Vials | 12/26/2019 | For the acute treatment of agitation in schizophrenic patients |
| 106 | 211196 | Penicillamine Tablets, 250 mg | Par Pharmaceutical, Inc. | Depen (Penicillamine) Tablets, 250 mg | 12/23/2019 | For the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy |
| 105 | 210128 |
Apixaban Tablets, 2.5 mg and 5 mg | Mylan | Eliquis (Apixaban)Tablets, 2.5 mg and 5 mg 12/23/2019 | 12/23/2019 | To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy |
| 104 | 210013 |
Apixaban Tablets, 2.5 mg and 5 mg | Micro Labs Limited | Eliquis (Apixaban)Tablets, 2.5 mg and 5 mg | 12/23/2019 | To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy |
| 103 | 211050 | Diazoxide Oral Suspension, 50 mg/mL | e5 Pharma, LLC | Proglycem (Diazoxide) Oral Suspension, 50 mg/mL | 12/20/2019 | For the management of hypoglycemia due to hyperinsulinism associated with certain conditions |
| 102 | 208295 | Alvimopan Capsules, 12 mg | Watson Laboratories, Inc. | Entereg (Alvimopan) Capsules, 12 mg | 12/19/2019 | To accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis |
| 101 | 208697 | Deferasirox Tablets, 90 mg, 180 mg and 360 mg | Actavis Elizabeth LLC | Jadenu (Deferasirox) Tablets, 90 mg, 180 mg, 360 mg | 12/13/2019 | For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older |
| 100 | 210830 | Etonogestrel and Ethinyl Estradiol Vaginal Ring, 0.120 mg/0.015 mg per day | Amneal Pharmaceuticals LLC | Nuvaring (Etonogestrel and Ethinyl Estradiol) Vaginal Ring, 0.120 mg/0.015 mg per day |
12/11/2019 | For use by women to prevent pregnancy |
| 99 | 210050 |
Everolimus Tablets, 2.5 mg, 5 mg, 7.5 mg, and 10 mg | Teva Pharmaceuticals USA, Inc. | Afinitor (Everolimus) Tablets, 2.5 mg, 5 mg, 7.5 mg, and 10 mg | 12/9/2019 | For the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; renal angiomyolipoma and tuberous sclerosis complex; progressive neuroendocrine tumors of pancreatic origin; and progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable |
| 98 | 207934 | Everolimus Tablets, 2.5 mg, 5 mg, 7.5 mg | Par Pharmaceutical | Afinitor (Everolimus) Tablets, 2.5 mg, 5 mg, 7.5 mg, and 10 mg | 12/9/2019 | For the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; renal angiomyolipoma and tuberous sclerosis complex; progressive neuroendocrine tumors of pancreatic origin; and progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable |
| 97 | 208014 | Fingolimod Capsules, 0.5 mg | Sun Pharmaceutical Industries Limited | Gilenya (Fingolimod) Capsules, 0.5 mg | 12/4/2019 | For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older |
| 96 | 207979 | Fingolimod Capsules, 0.5 mg | Biocon Limited | Gilenya (Fingolimod) Capsules, 0.5 mg | 12/4/2019 | For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older |
| 95 | 207939 | Fingolimod Capsules, 0.5 mg | HEC Pharm Co., Ltd. | Gilenya (Fingolimod) Capsules, 0.5 mg | 12/4/2019 | For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older |
| 94 | 209356 | Sucralfate Oral Suspension, 1 g/10 mL | Amneal Pharmaceuticals LLC | Carafate (Sucralfate) Oral Suspension, 1 g/10 mL | 12/2/2019 | For the short-term (up to 8 weeks) treatment of active duodenal ulcer |
| 93 | 209223 | Deferasirox Tablets, 90 mg, 180 mg, 360 mg | Teva Pharmaceuticals USA, Inc | Jadenu (Deferasirox) Tablets, 90 mg, 180 mg, 360 mg | 11/25/2019 | For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older |
| 92 | 211383 | Deferasirox Tablets, 90 mg, 180 mg, 360 mg | Zydus Pharmaceuticals (USA), Inc | Jadenu (Deferasirox) Tablets, 90 mg, 180 mg, 360 mg | 11/20/2019 | For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older |
| 91 | 211824 | Deferasirox Tablets, 90 mg, 180 mg, 360 mg | Alembic Pharmaceuticals Limited | Jadenu (Deferasirox) Tablets, 90 mg, 180 mg, 360 mg | 11/20/2019 | For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and olde |
| 90 | 210945 | Deferasirox Tablets, 90 mg, 180 mg, 360 mg, | MSN Pharmaceuticals, Inc. | Jadenu (Deferasirox) Tablets, 90 mg, 180 mg, 360 mg | 11/20/2019 | For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older |
| 89 | 207271 | Mesalamine Extended-Release Capsules, USP 0.375 g, | Mylan Pharmaceuticals Inc. | Apriso (Mesalamine) Extended-Release Capsules, USP 0.375 g, | 11/1/2019 | For the maintenance of remission of ulcerative colitis in patients 18 years of age and older |
| 88 | 210016 | Gadoterate Meglumine Injection, 5 mmol /10 mL (0.5 mmol/mL) 7.5 mmol/15 mL (0.5 mmol/mL), 10 mmol/20 mL (0.5 mmol/mL) Single-Dose Vials | GE Healthcare Inc. | Clariscan (Gadoterate Meglumine) Injection 5 mmol /10 mL (0.5 mmol/mL) 7.5 mmol/15 mL (0.5 mmol/mL), 10 mmol/20 mL (0.5 mmol/mL) Single-Dose Vials, | 11/1/2019 | For intravenous use with magnetic resonance imaging in brain, spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity |
| 87 | 213000 | Digoxin Oral Solution USP, 0.05 mg/ mL | Novitium Pharma, LLC | Digoxin Oral Solution, 0.05 mg/mL | 10/4/2019 | For the treatment of atrial fibrillation in adults and heart failure in adult and pediatric patients |
| 86 | 208212 | Vilazodone Hydrochloride Tablets, 10 mg, 20 mg, and 40 mg | Teva Pharmaceuticals | Viibryd (Vilazodone Hydrochloride) Tablets, 10 mg, 20 mg, and 40 mg | 9/30/2019 | For the treatment of major depressive disorder |
| 85 | 210019 | Ivermectin Cream, 1% | Teva Pharmaceuticals USA, Inc. | Soolantra (Ivermectin) Cream, 1% | 9/13/2019 | For the treatment of inflammatory lesions of rosacea |
| 84 | 209422 | Carfilzomib for Injection, 60 mg Single-Dose Vial | Dr. Reddy’s Laboratories Limited | Kyprolis (Carfilzomib) for Injection, 60 mg Single-Dose Vial | 9/9/2019 | For the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy |
| 83 | 204015 |
Fosaprepitant for Injection, 115 mg | Mylan Pharmaceuticals Inc. | Emend (Fosaprepitant) for Injection, 115 mg | 9/5/2019 | For the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy |
| 82 | 203166 | Nabumetone Tablets USP, 500 mg, 750 mg, and 1,000 mg | Nexgen Pharma, Inc. | Relafen (Nabumetone) Tablets, 500 mg, 750 mg, and 1,000 mg | 8/30/2019 | For relief of signs and symptoms of osteoarthritis and rheumatoid arthritis |
| 81 | 211041 | Nitisinone Capsules, 2 mg, 5 mg, and 10 mg | Notivium Pharma LLC | Orfadin (Nitisinone) Capsules, 2 mg, 5 mg, and 10 mg | 8/26/2019 | For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine |
| 80 | 212411 | Posaconazole Delayed-Release Tablets, 100 mg | Sinotherapeutics Inc | Noxafil (Posaconazole) Delayed-Release Tablets, 100 mg | 8/21/2019 | For the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised |
| 79 | 210027 | Sapropterin Dihydrochloride Powder for Oral Solution, 500 mg/ packet | Par Pharmaceutical, Inc. | Kuvan (Sapropterin Dihydrochloride) Powder for Oral Solution, 500 mg/ packet | 8/20/2019 | For the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) |
| 78 | 207207 | Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg/ packet | Par Pharmaceutical, Inc. | Kuvan (Sapropterin Dihydrochloride) Powder for Oral Solution, 100 mg/ packet | 8/20/2019 | For the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) |
| 77 | 211581 | Triamterene Capsules USP, 50 mg and 100 mg | Agnitio Inc. | Dyrenium (Triamterene) Capsules, 50 mg and 100 mg | 8/19/2019 | For the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism |
| 76 | 209051 | Tafluprost Ophthalmic Solution, 0.0015% | Micro Labs Limited | Zioptan (Tafluprost) Ophthalmic Solution, 0.0015% | 8/12/2019 | For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
| 75 | 211027 |
Halcinonide Cream USP, 0.1% | Mylan Pharmaceuticals Inc. | Halog (Halcinonide) Cream, 0.1% | 8/12/2019 | For the relief of inflammatory dermatoses |
| 74 | 210610 |
Morphine Sulfate Tablets, 15 mg and 30 mg | Upsher-Smith Laboratories, LLC | Morphine Sulfate Tablets, 15 mg and 30 mg | 7/22/2019 | For the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| 73 | 211384 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | InvaGen Pharmaceuticals, Inc. | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 72 | 210432 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg 300 mg | Rising Pharmaceuticals, Inc. | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 71 | 209743 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Amneal Pharmaceuticals | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 70 | 209664 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Dr Reddys Laboratories | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 69 | 209357 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Msn Laboratories Private Ltd | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 68 | 208677 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Sciegen Pharmaceuticals Inc | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 67 | 207799 | Pregabalin Capsules, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Alkem Laboratories Ltd | Lyrica (Pregabalin) Capsules, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 66 | 207623 | Pregabalin Oral Solution, 20 mg/mL | Alkem Laboratories | Lyrica (Pregabalin) Oral Solution, 20 mg/mL | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 65 | 203459 | Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Alembic Pharmaceuticals | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 64 | 91224 | Pregabalin Capsules, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | Teva Pharmaceuticals | Lyrica (Pregabalin) Capsules, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 63 | 91219 | Pregabalin Capsules, 25 mg, 50 mg | Teva Pharmaceuticals | Lyrica (Pregabalin) Capsules, 25 mg, 50 mg | 7/19/2019 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; for the management of postherpetic neuralgia; adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older; for the management of fibromyalgia; for the management of neuropathic pain associated with spinal cord injury |
| 62 | 210118 | Icatibant Injection, 30 mg/3 mL (10 mg/mL) | Teva Pharmaceuticals USA, Inc. | Firazyr (Icatibant) Injection, 30 mg/ 3 mL (10 mg/mL) | 7/15/2019 | For the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older |
| 61 |
212667 | Daptomycin for Injection, 350 mg/ vial (50 mg/mL) | Accord Healthcare Inc. | Daptomycin for Injection, 350 mg/ vial (50 mg/mL) | 7/12/2019 | For the treatment of complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia), in adult patients |
| 60 | 208994 | Kit for the Preparation of Technetium Tc99m Mertiatide, 1 mg/vial | Pharmalucence Inc. | Technescan MAG3™ (Kit for the Preparation of Technetium Tc99m Mertiatide) Injection, 1 mg/vial | 7/12/2019 | For the use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients |
| 59 | 211941 |
Carboprost Tromethamine Injection USP, 250 mcg/ mL (1 mL) Single-dose Vial | Dr. Reddy's Laboratories Limited | Hemabate (Carboprost Tromethamine) Injection, 250 mcg/ mL (1 mL) Single-dose Vial | 7/2/2019 | For aborting pregnancy between the 13th and 20th weeks of gestation |
| 58 | 210183 |
Phenylephrine and Ketorolac Intraocular Solution, 1%/ 0.3% | Lupin Limited | Omidria (Phenylephrine and Ketorolac) Intraocular Solution, 1%/ 0.3% | 7/1/2019 | For maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain during cataract surgery or intraocular lens replacement |
| 57 | 205467 |
Febuxostat Tablets, 40 mg and 80 mg | Sun Pharmaceutical Industries Limited | Uloric (Febuxostat) Tablets, 40 mg and 80 mg | 7/1/2019 | For the chronic management of hyperuricemia in adult patients with gout |
| 56 | 205421 | Febuxostat Tablets, 40 mg and 80 mg |
Alembic Pharmaceuticals Limited | Uloric (Febuxostat) Tablets, 40 mg and 80 mg | 7/1/2019 | For the chronic management of hyperuricemia in adult patients with gout |
| 55 | 205385 |
Febuxostat Tablets, 40 mg and 80 mg | Mylan Pharmaceuticals Inc. | Uloric (Febuxostat) Tablets, 40 mg and 80 mg | 7/1/2019 | For the chronic management of hyperuricemia in adult patients with gout |
| 54 | 208708 | Tramadol Hydrochloride Tablets USP, 100 mg | Rubicon Research Private Limited |
Ultram (Tramadol Hydrochloride) Tablets,100 mg | 6/28/2019 | For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| 53 | 210915 | Tobramycin Inhalation Solution USP, 300 mg/4 mL | Teva Pharmaceuticals USA, Inc. | Bethkis (Tobramycin) Inhalation Solution, 300 mg/4 mL | 6/26/2019 | For the management of cystic fibrosis patients with Pseudomonas aeruginosa |
| 52 | 210191 | Dapsone Gel, 7.5% | Taro Pharmaceuticals Inc. | Aczone (Dapsone) Gel, 7.5% | 6/26/2019 | For the topical treatment of acne vulgaris in patients 12 years of age and older |
| 51 | 208786 | Diclofenac Sodium Injection, 37.5 mg/mL Single-Dose Vials | Mylan Laboratories Limited | Dyloject (Diclofenac Sodium) Injection, 37.5 mg/mL Single-Dose Vials | 6/18/2019 | For the management of mild to moderate pain; management of moderate to severe pain alone or in combination with opioid analgesics |
| 50 | 212260 | Sildenafil for Oral Suspension, 10 mg/mL | Novitium Pharma LLC | Revatio (Sildenafil) for Oral Suspension, 10 mg/mL | 5/31/2019 | For the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening |
| 49 | 204902 | Dapiprazole Hydrochloride Ophthalmic Solution, 0.5% | Baradaina, LLC. | Dapiprazole Hydrochloride Ophthalmic Solution, 0.5% | 5/29/2019 | For the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents |
| 48 | 207344 | Micafungin for Injection, 50 mg/vial and 100 mg/vial Single-Dose Vials | Fresenius Kabi USA, LLC. | Mycamine for Injection, 50 mg/vial and 100 mg/vial | 5/17/2019 | For the treatment candidemia, acute disseminated candidiasis, candida peritonitis and abscesses; also for the treatment esophageal Candidiasis and prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation |
| 47 | 207200 | Sapropterin Dihydrochloride Tablets, 100 mg | Par Pharmaceutical, Inc | Kuvan (Sapropterin Dihydrochloride) Tablets, 100 mg | 5/10/2019 | For the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) |
| 46 | 207873 | Mesalamine Delayed-Release Capsules, 400 mg | Teva Pharmaceuticals USA, Inc. | Delzicol (Mesalamine) Delayed-Release Capsules, 400 mg | 5/9/2019 | For the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older; Maintenance of remission of ulcerative colitis in adults |
| 45 | 209921 | Penicillamine Capsules USP, 250 mg | Amerigen Pharmaceuticals, Ltd. | Cuprimine (Penicillamine) Capsules, 250 mg | 5/7/2019 | For the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy |
| 44 | 210762 | Fentanyl Citrate Injection USP, 50 mcg (base)/1 mL, 100 mcg (base)/2 mL (50 mcg/mL), 250 mcg (base)/5 mL (50 mcg/mL), 1,000 mcg (base)/20 mL (50 mcg/mL), and 2,500 mcg (base)/50 mL (50 mcg/mL)Single-dose Vials (Preservative Free) | Fresenius Kabi USA, LLC | Fentanyl Citrate Injection, 100 mcg (base)/2 mL (50 mcg/mL), 250 mcg (base)/5 mL (50 mcg/mL), 1,000 mcg (base)/20 mL (50 mcg/mL), and 2,500 mcg (base)/50 mL (50 mcg/mL) | 5/3/2019 | For analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises; for opioid analgesia supplementation in general or regional anesthesia |
| 43 | 209742 | Bosentan Tablets, 62.5 mg, 125 mg | Amneal Pharmaceuticals Company GmbH | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 42 | 209324 | Bosentan Tablets, 62.5 mg, 125 mg | Sun Pharmaceutical Industries Limited | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 41 | 208695 | Bosentan Tablets, 62.5 mg, 125 mg | West-Ward Pharmaceuticals International Limited | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 40 | 207110 | Bosentan Tablets, 62.5 mg, 125 mg | Watson Laboratories, Inc. | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 39 | 206987 | Bosentan Tablets, 62.5 mg, 125 mg | Natco Pharma Limited | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 38 | 207760 | Bosentan Tablets, 62.5 mg, 125 mg | Zydus Pharmaceuticals (USA) Inc. | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 37 | 206002 | Bosentan Tablets, 62.5 mg, 125 mg | Alvogen Pine Brook LLC | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 36 | 205699 | Bosentan Tablets, 62.5 mg, 125 mg | Par Pharmaceutical, Inc. | Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg | 4/26/2019 | For the treatment for pulmonary arterial hypertension |
| 35 | 206667 | Pentamidine Isethionate for Inhalation Solution, 300 mg/vial | Seton Pharmaceuticals, LLC | NebuPent (Pentamidine Isethionate) Powder for inhalation Solution, 300 mg/vial | 4/24/2019 | For the prevention of Pneumocystis jiroveci pneumonia (PJP) in high risk, HIV-infected patients defined by one or both of the following crtieria: (i) a history of one or more episodes of PJP; (ii) a peripheral CD4+ lymphocyte count less than 200/mm |
| 34 | 211388 | Rufinamide Oral Suspension, 40 mg/mL | Bionpharma Inc. | Banzel (Rufinamide) Oral Suspension, 40 mg/mL | 4/23/2019 | For the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) |
| 33 | 207363 | Rufinamide Oral Suspension, 40 mg/mL | Hikma Pharmaceuticals International Limited | Banzel (Rufinamide) Oral Suspension, 40 mg/mL | 4/23/2019 | For the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) |
| 32 | 210130 | Everolimus Tablets for Oral Suspension, 2 mg, 3 mg, 5 mg | Mylan Pharmaceuticals, Inc. | Afinitor Disperz (Everolimus) Tablets for Oral Suspension, 2 mg, 3 mg, 5 mg | 4/19/2019 | For the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected |
| 31 | 209522 | Naloxone Hydrochloride Nasal Spray, 4 mg/spray | Teva Pharmaceuticals USA, Inc. | Narcan (Naloxone Hydrochloride) Nasal Spray, 4 mg/spray | 4/19/2019 | For the emergency treatment of known or suspected opioid overdose |
| 30 | 209371 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL | Aurobindo Pharma Limited | Augmentin (Amoxicillin and Clavulanate Potassium) for Oral Suspension USP, 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL | 4/19/2019 | For treatment of lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections |
| 29 | 206430 | Valrubicin Intravesical Solution USP, 200 mg/5 mL(40 mg/mL) in Single Dose Vials | Custopharm, Inc. | Valstar (Valrubicin) Intravesical Solution USP, 200 mg/5 mL (40 mg/mL) in Single Dose Vials | 4/19/2019 | For the intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality |
| 28 | 207609 | Loteprednol Etabonate Ophthalmic Suspension, 0.5% | Hi-tech Pharmacal Co., Inc. | Lotemax (Loteprednol Etabonate) Ophthalmic Suspension, 0.5% | 4/17/2019 | For the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis |
| 27 | 091178 | Mifepristone Tablets, 200 mg | GenBioPro, Inc. | Mifeprex (Mifepristone) Tablets, 200 mg | 4/11/2019 | For the medical termination of intrauterine pregnancy through 70 days gestation |
| 26 | 208201 | Naftifine Hydrochloride Gel USP, 2% | Taro Pharmaceuticals U.S.A. Inc. | Naftin (Naftifine Hydrochloride) Gel, 2% | 4/10/2019 | For the treatment of interdigital tinea pedis |
| 25 | 208441 |
Ambrisentan Tablets, 5 mg, 10 mg |
Mylan Pharmaceuticals Inc. | Letairis (Ambrisentan) Tablets, 5 mg, 10 mg | 3/28/2019 | For the treatment of pulmonary arterial hypertension |
| 24 | 208252 | Ambrisentan Tablets, 5 mg, 10 mg | Watson Laboratories, Inc | Letairis (Ambrisentan) Tablets, 5 mg, 10 mg | 3/28/2019 | For the treatment of pulmonary arterial hypertension |
| 23 | 210784 |
Ambrisentan Tablets, 5 mg, 10 mg |
Sun Pharma Global FZE | Letairis (Ambrisentan) Tablets, 5 mg, 10 mg | 3/28/2019 | For the treatment of pulmonary arterial hypertension |
| 22 | 210058 |
Ambrisentan Tablets, 5 mg, 10 mg |
Zydus Pharmaceuticals (USA) Inc. | Letairis (Ambrisentan) Tablets, 5 mg, 10 mg | 3/28/2019 | For the treatment of pulmonary arterial hypertension |
| 21 | 206665 | Aliskiren Tablets, 150 mg, 300 mg | Anchen Pharmaceuticals, Inc. | Tekturna (Aliskiren) Tablets, 150 mg, 300 mg | 3/22/2019 | For the treatment of hypertension in adults |
| 20 | 206165 | Naftifine Hydrochloride Gel, 1% | Tolmar, Inc. | Naftin (Naftifine Hydrochloride) Gel, 1% | 3/20/2019 | For the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum |
| 19 | 211694 | Pyridostigmine Bromide Syrup, 60 mg/5 mL | Novitium Pharma LLC | Mestinon (Pyridostigmine Bromide) Syrup, 60 mg/5 mL | 3/8/2019 | To improve muscle strength in patients with myasthenia gravis |
| 18 | 206066 | Bepotastine Besilate Ophthalmic Solution, 1.5% | Apotex Inc. | Bepreve (Bepotastine Besilate) Ophthalmic Solution, 1.5% | 3/8/2019 | For the treatment of itching associated with signs and symptoms of allergic conjunctivitis |
| 17 | 209202 | Esomeprazole Magnesium Delayed-Release Tablets, 20 mg (base) (OTC) | Actavis Elizabeth LLC | Nexium 24HR (Esomeprazole Magnesium) Delayed-Release Tablets, 20 mg (base) (OTC) | 3/6/2019 | For the treatment of frequent heartburn |
| 16 | 210044 | Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) | Amneal Pharmaceuticals Company GmbH | Faslodex (Fulvestrant) Injection, 250 mg/5 mL (50 mg/mL) | 3/4/2019 | For the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy |
| 15 | 205600 | Levofloxacin Ophthalmic Solution, 1.5% | Micro Labs Limited, India | Iquix (Levofloxacin) Opthalmic Solution, 1.5% | 2/27/2019 | For the treatment of corneal ulcer caused by susceptible strains of the following bacteria |
| 14 | 208800 | Deferiprone Tablets, 500 mg | Taro Pharmaceuticals Industries Limited | Ferriprox (Deferiprone) Tablets, 500 mg | 2/8/2019 | For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate |
| 13 | 204724 | Sevelamer Hydrochloride Tablets, 400 mg, 800 mg | Glenmark Pharmaceuticals Limited | Renagel (Sevelamer Hydrochloride) Tablets, 400 mg, 800 mg | 2/8/2019 | For the control of serum phosphorus in patients with chronic kidney disease on dialysis |
| 12 | 210790 | Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, 120 mg | Amneal Pharmaceuticals Company GmbH | Fetzima (Levomilnacipran) Extended-Release Capsules, 20 mg, 40 mg, 80 mg, 120 mg | 2/4/2019 | For the treatment of Major Depressive Disorder |
| 11 | 208702 | Acyclovir Cream, 5% | Perrigo UK FINCO Limited Partnership | Zovirax (Acyclovir) Cream, 5% | 2/4/2019 | For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older |
| 10 | 208891 | Wixela Inhub (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg | Mylan Pharmaceuticals Inc. | Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg | 1/30/2019 |
For the treatment of asthma in patients aged 4 years and older; and for the 250/50 strength, for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| 9 | 211040 | Sirolimus Oral Solution, 1 mg/mL | Novitium Pharma LLC | Rapamune (Sirolimus) Oral Solution, 1 mg/mL | 1/28/2019 |
For the prophylaxis of organ rejection in patients aged 13 years of age or older receiving renal transplants |
| 8 | 209822 | Vigabatrin Tablets USP, 500 mg | Teva Pharmaceuticals USA, Inc. | Sabril (Vigabatrin) Tablets, 500 mg | 1/14/2019 | For the treatment of refractory complex partial seizures (CPS) in patients 10 years of age and older who have responded inadequately to several alternative treatments |
| 7 | 209019 | Ingenol Mebutate Gel, 0.05% | Perrigo UK FINCO Limited Partnership | Picato Gel (Ingenol Mebutate) Gel, 0.05% | 1/9/2019 | For the topical treatment of actinic keratosis |
| 6 | 209018 | Ingenol Mebutate Gel, 0.015% | Perrigo UK FINCO Limited Partnership | Picato Gel (Ingenol Mebutate) Gel, 0.015% | 1/7/2019 | For the topical treatment of actinic keratosis |
| 5 | 208055 | Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 80 mg, 120 mg | Torrent Pharmaceuticals Limited | Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 80 mg, 120 mg | 1/3/2019 | For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults |
| 4 | 208049 | Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg | Accord Healthcare Inc. | Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | 1/3/2019 | For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults |
| 3 | 208031 | Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | Lupin Limited | Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | 1/3/2019 | For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults |
| 2 | 208028 | Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | InvaGen Pharmaceuticals, Inc. | Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | 1/3/2019 | For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults |
| 1 | 208002 | Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | Amneal Pharmaceuticals Company GmbH | Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg | 1/3/2019 |
For the treatment of depressive episode associated with Bipolar I Disorder (bipolar depression) in adults |
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.