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 2021*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 40 | 212248 | 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) Single Dose Vial | Fresenius Kabi USA, LLC | 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) | 4/28/2021 | Additive in parenteral fluid therapy for use in patients who have special problem of sodium electrolyte intake or excretion |
| 39 | 212070 | Sodium Chloride Injection, USP, 14.6% 50 mEq/20 mL and 100 mEq/40 mL | Fresenius Kabi USA, LLC | Sodium Chloride Injection, USP 14.6% 50 mEq/20 mL and 100 mEq/40 mL | 4/28/2021 | For the parenteral restoration of sodium ion in patients with restricted oral intake |
| 38 | 214326 | Tiopronin Tablets, 100 mg | Teva Pharmaceuticals USA, Inc | Thiola (Tiopronin) Tablets, 100 mg | 4/26/2021 | For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone |
| 37 | 213313 | Pregabalin Extended-Release Tablets, 165 mg, 330 mg | Apotex | Lyrica CR (Pregabalin) Extended-Release Tablets, 165 mg, 330 mg | 4/13/2021 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia |
| 36 | 213226 | Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg | MSN Laboratories Private Limited | Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg | 4/13/2021 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia |
| 35 | 211948 | Pregabalin Extended-Release Tablets, 82.5 mg | Mylan Pharmaceuticals Inc. | Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg | 4/13/2021 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia |
| 34 | 211889 | Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg | Sun Pharmaceutical Industries Limited | Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg | 4/13/2021 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia |
| 33 | 211593 | Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg | Alvogen Pine Brook LLC | Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg | 4/13/2021 | For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia |
| 32 | 206888 | Tirofiban Hydrochloride Injection, 12.5 mg/250 mL (50 mcg/mL) Single-Dose Container | Gland Pharma Limited | Aggrastat (Tirofiban Hydrochloride) Injection, 12.5 mg/250 mL (50 mcg/mL) | 4/8/2021 | For the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy |
| 31 | 211224 | Macitentan Tablets, 10 mg | Zydus Worldwide DMCC | Opsumit (Macitentan) Tablets, 10 mg | 4/6/2021 | For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH |
| 30 | 212296 | Deoxycholic Acid Injection, 20 mg/2 mL (10 mg/mL) (Single-Dose Vial) | Slayback Pharma LLC | Kybella (Deoxycholic Acid) Injection, 20 mg/2 mL (10 mg/mL) | 4/2/2021 | For improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults |
| 29 | 211344 | Ibrutinib Capsules, 70 mg and 140 mg | Zydus Worldwide DMCC | Imbruvica (Ibrutinib) Capsules, 70 mg and 140 mg | 3/31/2021 | For the treatment of adult patients with mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma , Waldenström’s macroglobulinemia, marginal zone lymphoma, or chronic graft versus host disease |
| 28 | 205063 | Isotretinoin Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg | Actavis Laboratories FL, Inc. | Absorica (Isotretinoin) Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg | 3/31/2021 | For the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater |
| 27 | 203451 | 50% Dextrose Injection USP, 25 g/50 mL (0.5 g/mL), Single-Dose Prefilled Syringes | International Medication Systems, Limited | 50% Dextrose Injection USP, 25 g/50 mL (0.5 g/mL), Single-Dose Prefilled Syringes | 3/26/2021 | For the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels and, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements |
| 26 | 213424 | Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial | Accord Healthcare Inc. | Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial | 3/19/2021 | For the temporary blockade of severe or life threatening muscarinic effects |
| 25 | 214727 | Potassium Chloride Injection, 10 mEq/100 mL (7.45 mg/mL), 10 mEq/50 mL (14.9 mg/mL), 20 mEq/100 mL (14.9 mg/mL), 20 mEq/50 mL (29.8 mg/mL), and 40 mEq/100 mL (29.8 mg/mL) Single-Dose Containers | Nexus Pharmaceuticals Inc. | Potassium Chloride Injection, 10 mEq/100 mL, 10 mEq/50 mL, 20 mEq/100 mL, 20 mEq/50 mL, and 40 mEq/100 mL | 3/18/2021 | For the treatment of potassium deficiency states when oral replacement is not feasible |
| 24 | 213523 | Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP, 10 mEq/1000 mL, 20 mEq/1000 mL, 30 mEq/1000 mL, and 40 mEq/1000 mL in Single-Dose Containers | Fresenius Kabi USA, LLC | Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection , 10 mEq/1000 mL, 20 mEq/1000 mL, 30 mEq/1000 mL, and 40 mEq/1000 mL | 3/9/2021 | For patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride |
| 23 | 213445 | Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP, 20 mEq/1,000 mL and 40 mEq/1,000 mL, Single-Dose Containers | Fresenius Kabi USA, LLC | Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP, 20 mEq/1,000 mL and 40 mEq/1,000 mL | 3/9/2021 | For patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride |
| 22 | 208269 | Hydrocodone Bitartrate Extended-Release Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg | Alvogen Pine Brook LLC | Hysingla ER (Hydrocodone Bitartrate Extended-Release) Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg | 3/1/2021 | 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 |
| 21 | 214391 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Ajanta Pharma Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 20 | 214387 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Aurobindo Pharma Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 19 | 214384 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Sun Pharmaceutical Industries Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 18 | 214017 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | ScieGen Pharmaceuticals, Inc. | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 17 | 213911 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Alkem Laboratories Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 16 | 213661 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Tasman Pharma Inc. | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 15 | 213162 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Teva Pharmaceuticals USA, Inc. | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 14 | 212835 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Hikma Pharmaceuticals USA Inc. | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 13 | 211818 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Zydus Pharmaceuticals (USA) Inc. | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 12 | 211741 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | MSN Laboratories Private Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 11 | 211726 | Droxidopa Capsules, 300 mg | Annora Pharma Private Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 10 | 211652 | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | Lupin Limited | Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension |
| 9 | 211819 | Apremilast Tablets, 10 mg, 20 mg and 30 mg | Unichem Laboratories Limited | Otezla (Apremilast) Tablets, 10 mg, 20 mg and 30 mg | 2/18/2021 | For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy |
| 8 | 212080 | Loteprednol Etabonate Ophthalmic Gel, 0.5% | Akorn Operating Company LLC | Lotemax (Loteprednol) Etabonate Ophthalmic Gel, 0.5% | 2/10/2021 | For the treatment of post-operative inflammation and pain following ocular surgery |
| 7 | 209564 | Linaclotide Capsules, 145 mcg and 290 mcg | Mylan Pharmaceuticals Inc. | Linzess (Linaclotide) Capsules, 145 mcg and 290 mcg | 2/9/2021 | For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation |
| 6 | 210278 | Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg | Glenmark Pharmaceuticals Inc., USA | Qudexy XR (Topiramate Extended-Release) Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg | 2/1/2021 | For the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older; preventive treatment of migraine in patients 12 years of age and older |
| 5 | 205971 | Imiquimod Cream USP, 3.75% | Taro Pharmaceutical Industries Limited | Zyclara (Imiquimod) Cream, 3.75% | 1/26/2021 | For the topical treatment of clinically typical, visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults; for the topical treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older |
| 4 | 214235 | Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial | Caplin Steriles Limited | Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial | 1/21/2021 | For the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia; as an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention |
| 3 | 210473 | Epoprostenol for Injection, 0.5 mg/Vial and 1.5 mg/Vial | Sun Pharmaceutical Industries Limited | Veletri (Epoprostenol for Injection), 0.5 mg/Vial and 1.5 mg/Vial | 1/15/2021 | For the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity |
| 2 | 206604 | Ferumoxytol Injection, 510 mg Iron/17 mL (30 mg/mL) Single-Dose Vials | Sandoz Inc. | Feraheme (Ferumoxytol) Injection, 510 mg Iron/17 mL (30 mg/mL) Single-Dose Vials | 1/15/2021 | For the treatment of iron deficiency anemia in adult patients who: have intolerance to oral iron or have had unsatisfactory response to oral iron; or who have chronic kidney disease |
| 1 | 213256 | Levothyroxine Sodium Capsules, 88 mcg, 100 mcg, and 125 mcg | Teva Pharmaceuticals USA, Inc. | Tirosint (Levothyroxine Sodium) Capsules, 88 mcg, 100 mcg, and 125 mcg | 1/6/2021 | For adults and pediatric patients 6 years and older with hypothyroidism |
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.