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+ | |
|---|---|---|---|---|---|---|
| 80 | 205775 | Everolimus Tablets, 0.25 mg, 0.5 mg, 0.75 mg and 1 mg | Par Pharmaceutical, Inc. | Zortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, 0.75 mg and 1 mg | 10/18/2021 | For the prophylaxis of organ rejection in adult patients |
| 79 | 209348 | Lenalidomide Capsules , 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg | Dr. Reddy's Laboratories Limited | Revlimid (Lenalidomide) Capsules , 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg | 10/14/2021 | For the treatment for multiple myeloma |
| 78 | 213729 | Carglumic Acid Tablets for Oral Suspension, 200 mg | Novitium Pharma LLC | Carbaglu (Carglumic Acid) Tablets for Oral Suspension, 200 mg | 10/14/2021 | For adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency; maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency |
| 77 | 209708 | Mivacurium Chloride Injection, 10 mg/5 mL (2 mg/mL) and 20 mg/10 mL (2 mg/mL) Single-dose Vials (Preservative Free) | Woodward Pharma Services, LLC | Mivacron (Mivacurium Chloride) Injection, 10 mg/5 mL (2 mg/mL) and 20 mg/10 mL (2 mg/mL) Single-dose Vials | 10/12/2021 | For inpatients and outpatients, as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation |
| 76 | 206254 | Romidepsin for Injection, 10 mg/vial, Single Dose Vial | Fresenius Kabi USA, LLC | Istodax (Romidepsin for Injection), 10 mg/vial | 10/12/2021 | For the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy |
| 75 | 213584 | Oxymetazoline Hydrochloride Cream, 1% | Taro Pharmaceuticals Inc. | Rhofade (Oxymetazoline Hydrochloride) Cream, 1% | 10/4/2021 | For the topical treatment of persistent facial erythema associated with rosacea in adults |
| 74 | 212469 | Zolmitriptan Nasal Spray USP, 2.5 mg and 5 mg | Padagis Israel Pharmaceuticals Ltd. | Zomig (Zolmitriptan) Nasal Spray USP, 2.5 mg and 5 mg | 9/30/2021 | For the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older |
| 73 | 209158 | Brimonidine Topical Gel, 0.33% | Padagis Israel Pharmaceuticals Ltd. | Mirvaso (Brimonidine) Topical Gel, 0.33% | 9/23/2021 | For the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older |
| 72 | 208075 | Ceftaroline Fosamil for Injection, 400 mg and 600 mg Single-Dose Vials | Apotex Inc. | Teflaro (Ceftaroline Fosamil) for Injection, 400 mg and 600 mg Single-Dose Vials | 9/21/2021 | For the treatment of acute bacterial skin and skin structure infections in adult and pediatric patients 2 months of age and older; community-acquired bacterial pneumonia in adult and pediatric patients 2 months of age and older |
| 71 | 211146 | Vortioxetine Tablets, 5 mg, 10 mg, and 20 mg | Zydus Pharmaceuticals (USA) Inc. | Trintellix (Vortioxetine) Tablets, 5 mg, 10 mg, and 20 mg | 9/17/2021 | Indicated for the treatment of major depressive disorder (MDD) in adults |
| 70 | 212463 | Eliglustat Capsules, 84 mg | Aizant Drug Research Solutions Pvt. Ltd. | Cerdelga (Eliglustat) Capsules, 84 mg | 9/8/2021 | For the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers as detected by an FDA-cleared test |
| 69 | 215003 | Paroxetine Oral Suspension, 10 mg (base)/5 mL | Novitium Pharma LLC | Paxil (Paroxetine) Oral Suspension, 10 mg/5 mL | 9/3/2021 | For the treatment of Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, and Posttraumatic Stress Disorder |
| 68 | 208335 | Linagliptin Tablets, 5 mg | Sunshine Lake Pharma Co., Ltd. | Tradjenta (Linagliptin) Tablets, 5 mg | 8/31/2021 | Adjunct treatement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| 67 | 208336 | Linagliptin and Metformin Hydrochloride Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg | Sunshine Lake Pharma Co., Ltd. | Jentadueto (Linagliptin and Metformin Hydrochloride) Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg | 8/30/2021 | Adjunct treatement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| 66 | 214264 | Tofacitinib Extended-Release Tablets, 11 mg and 22 mg | Zydus Pharmaceuticals (USA) Inc | Xeljanz XR (Tofacitinib) Extended-Release Tablets, 11 mg and 22 mg | 8/19/2021 | For the treatment of adult patients with moderately to severely active rheumatoid arthritis; active psoriatic arthritis; moderately to severely active ulcerative colitis |
| 65 | 213914 | Sunitinib Malate Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg | Sun Pharmaceutical Industries Limited | Sutent (Sunitinib Malate) Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg | 8/16/2021 | For the treatment of adult patients with gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate; treatment of adult patients with advanced renal cell carcinoma (RCC); adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy; treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in adult patients with unresectable locally advanced or metastatic disease |
| 64 | 213070 | Loperamide Hydrochloride Capsules USP, 2 mg (OTC) | Strides Pharma Global Pte. Limited | Loperamide Hydrochloride Capsules USP, 2 mg (OTC) | 8/11/2021 | Controls symptoms of diarrhea, including Travelers’ Diarrhea |
| 63 | 201785 | Varenicline Tablets, 0.5 mg and 1 mg | Par Pharmaceutical, Inc. | Chantix (Varenicline) Tablets, 0.5 mg and 1 mg | 8/11/2021 | For use as an aid to smoking cessation treatment |
| 62 | 212408 | Enalapril Maleate Oral Solution, 1 mg/mL | Bionpharma Inc. | Epaned (Enalapril Maleate) Oral Solution, 1 mg/mL | 8/10/2021 | For the treatment of symptomatic heart failure; and asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure |
| 61 | 211776 | Difluprednate Ophthalmic Emulsion, 0.05% | Cipla Limited | Durezol (Difluprednate) Ophthalmic Emulsion, 0.05% | 8/9/2021 | For the treatment of inflammation and pain associated with ocular surgery and treatment of endogenous anterior uveitis |
| 60 | 204438 | Glycopyrrolate Oral Solution, 1 mg/5 mL (0.2 mg/mL) | Par Pharmaceutical, Inc. | Cuvposa (Glycopyrrolate) Oral Solution, 1 mg/5 mL (0.2 mg/mL) | 8/9/2021 | To reduce chronic severe drooling in patients aged 3 to16 years with neurologic conditions associated with problem drooling. |
| 59 | 211890 | Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg | Alkem Laboratories Limited | Duexis (Ibuprofen and Famotidine) Tablets, 800 mg/26.6 mg | 8/3/2021 | For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers |
| 58 | 211594 | Buprenorphine Buccal Film, 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg | Alvogen Malta Operations Ltd. | Belbuca (Buprenorphine) Buccal Film, 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg | 8/3/2021 | For the management of pain severe enough to require daily around the clock long-term opioid treatment for which alternative treatment options are inadequate |
| 57 | 212348 | Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection USP, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) in Single-Dose Containers | Fresenius Kabi USA, LLC | Potassium Chloride in 5% Dextrose & 0.225% Sodium Chloride Injection USP, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) | 7/30/2021 | For the treatmentpatients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride |
| 56 | 212868 | Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe | Accord Healthcare Inc. | Atropine Sulfate Injection USP, 0.25 mg/5 mL, 0.5 mg/5 mL, 1 mg/10mL | 7/26/2021 | For the temporary blockade of severe or life threatening muscarinic effects |
| 55 | 211149 | Paliperidone Palmitate Extended-Release Injectable Suspension, 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL | Teva Pharmaceuticals USA, Inc. | Invega Sustenna (Paliperidone Palmitate) Extended-Release Injectable Suspension, 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL | 7/6/2021 | For the treatment of schizophrenia in adults; schizoaffective disorder in adults |
| 54 | 211238 | Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, 800 mg | Dr. Reddy's Laboratories Inc. | Aptiom (Eslicarbazepine Acetate) Tablets, 200 mg, 400 mg, 600 mg, 800 mg | 6/29/2021 | For the adjunctive treatment of partial-onset seizures |
| 53 | 213762 | Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials | Axar Pharmaceuticals, Inc. | Brovana (Arformoterol Tartrate) Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials | 6/22/2021 | For the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema |
| 52 | 213132 | Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials | Glenmark Pharmaceuticals Limited | Brovana (Arformoterol Tartrate) Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials | 6/22/2021 | For the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema |
| 51 | 207306 | Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL Single-Dose Vial | Cipla USA, Inc. | Perforomist (Formoterol Fumarate) Inhalation Solution, 20 mcg/2 mL Single-Dose Vial | 6/22/2021 | For the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema |
| 50 | 091141 | Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL Single-Dose Vial | Teva Pharmaceuticals USA, Inc. | Perforomist (Formoterol Fumarate) Inhalation Solution, 20 mcg/2 mL Single-Dose Vial | 6/22/2021 | For the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema |
| 49 | 214196 | Etravirine Tablets, 25 mg, 100 mg, and 200 mg | Amneal EU, Limited | Intelence (Etravirine) Tablets, 25 mg, 100 mg, and 200 mg | 6/14/2021 | For the treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older |
| 48 | 209330 | Carfilzomib for Injection, 10 mg, 30 mg, and 60 mg Single-Dose Vials | Breckenridge Pharmaceutical, Inc. | Kyprolis (Carfilzomib) for Injection, 10 mg, 30 mg, and 60 mg Single-Dose Vials | 6/11/2021 | For the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone |
| 47 | 091677 | Lopinavir and Ritonavir Tablets USP, 100 mg/25 mg, 200 mg/50 mg | Hetero Labs Limited | Kaletra (Lopinavir and Ritonavir) Tablets, 100 mg/25 mg and 200 mg/50 mg | 6/4/2021 | For the treatment of HIV-1 infection in adults and pediatric patients (14 days and older) |
| 46 | 212943 | Tofacitinib Tablets, 10 mg | Ajanta Pharma Limited | Xeljanz (Tofacitinib) Tablets, 10 mg | 6/1/2021 | For the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and active polyarticular course juvenile idiopathic arthritis |
| 45 | 212007 | Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials | Exela Pharma Sciences, LLC. | Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials | 5/21/2021 | For use as a supplement to intravenous solutions given for total parenteral nutrition (TPN) |
| 44 | 201452 | Lenalidomide Capsules, 5 mg, 10 mg, 15 mg and 25 mg | Natco Pharma Limited | Revlimid (Lenalidomide) Capsules, 5 mg, 10 mg, 15 mg and 25 mg | 5/21/2021 | For the treatment of multiple myeloma; transfusion-dependent anemia; mantle cell lymphoma; previously treated follicular lymphoma; previously treated marginal zone lymphoma |
| 43 | 212416 | Calcitonin Salmon Injection USP, 400 USP units per 2 mL (200 USP units per mL) Multi-Dose Vial | Custopharm, Inc. | Miacalcin (Calcitonin Salmon) Injection USP, 400 USP units per 2 mL (200 USP units per mL) Multi-Dose Vial | 5/14/2021 | Treatment of symptomatic Paget’s disease; hypercalcemia; postmenopausal osteoporosis |
| 42 | 209614 | Enzalutamide Capsules, 40 mg | Actavis Laboratories FL, Inc | Xtandi (Enzalutamide) Capsules, 40 mg | 5/14/2021 | For the treatment of patients with castration-resistant prostate cancer |
| 41 | 214805 | Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials | Milla Pharmaceuticals, Inc. | Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials | 5/4/2021 | Indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake |
| 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.