1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. First Generic Drug Approvals
  1. Drug and Biologic Approval and IND Activity Reports

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 2026*

 ANDA NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
77219647Tramadol Hydrochloride Oral SolutionNovitium Pharma LLCQdolo Oral Solution6/26/2026For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.
76217769Ferric Carboxymaltose InjectionMylan Pharmaceuticals Inc.Injectafer Injection6/25/2026For the treatment of iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron and adult patients who have non-dialysis dependent chronic kidney disease. 
75217076Ferric Carboxymaltose InjectionMylan Pharmaceuticals Inc.Injectafer Injection6/25/2026For the treatment of iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron and adult patients who have non-dialysis dependent chronic kidney disease. 
74212572Ferric Carboxymaltose InjectionMylan Laboratories LimitedInjectafer Injection6/25/2026For the treatment of iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron and adult patients who have non-dialysis dependent chronic kidney disease. 
73217042Rifapentine TabletMacleods Pharmaceuticals LimitedPriftin Tablet6/23/2026Indicated in adults and pediatric patients 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible.
72218722Solriamfetol Hydrochloride TabletAlkem Laboratories LimitedSunosi Tablet6/17/2026Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
71218016Solriamfetol Hydrochloride TabletHikma Pharmaceuticals USA Inc.Sunosi Tablet6/17/2026Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
70217449Baloxavir Marboxil TabletNorwich Pharmaceuticals, Inc.Xofluza Tablet6/17/2026For treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.
69217329Fostamatinib Disodium TabletAnnora Pharma Private LimitedTavalisse Tablet6/17/2026For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
68209624Bosutinib Monohydrate TabletMSN Laboratories Private LimitedBosulif Tablet6/12/2026For the treatment of: Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy and Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy.
67219099Romidepsin InjectionAmneal EU, LimitedRomidepsin Injection6/2/2026For the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. 
66220562Epinephrine InjectionHikma Pharmaceuticals USA Inc.Epinephrine Injection5/29/2026Indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
65216095Sodium Sulfate, Magnesium Sulfate, Potassium Chloride TabletLupin LimitedSutab Tablet5/28/2026For the cleansing of the colon as a preparation for colonoscopy in adults. 
64214733Venetoclax TabletDr. Reddy's Laboratories LimitedVenclexta Tablet5/15/2026For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 
63219189Gallium Ga 68 Gozetotide InjectionIonetix CorporationGallium Ga 68 Gozetotide Injection5/14/2026For positron emission tomography (PET) of prostatespecific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and  with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 
62220717Zolpidem Tartrate CapsuleUmedica Laboratories Pvt. Ltd.Zolpidem Tartrate Capsule5/12/2026For the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age .
61212069Vasopressin InjectionSandoz Inc.Vasostrict Injection5/6/2026Indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. 
60213267Thalidomide CapsuleNatco Pharma LimitedThalomid Capsule4/24/2026For the treatment of patients with newly diagnosed multiple myeloma (MM) in combination with dexamethasone.
59219409Albuterol Sulfate Inhalation AerosolCipla LimitedVentolin HFA Inhalation Aerosol4/22/2026For the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 
58210671Multiple Vitamins Injection Pediatric SDVApotex Inc.Infuvite Injection Pediatric4/21/2026For the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. 
57210456Multiple Vitamins Injection Pediatric PBPApotex Inc.Infuvite Injection Pediatric4/21/2026For the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. 
56216068Enzalutamide TabletSandoz Inc.Xtandi Tablet4/20/2026For the treatment of patients with: castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).
55210449Canagliflozin TabletApotex Inc.Invokana Tablet4/14/2026Indicatecd as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
54210672Multiple Vitamins Injection Adult PBPApotex Inc.Infuvite Injection Adult4/9/2026For the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. 
53210273Multiple Vitamins Injection Adult SDVApotex Inc.Infuvite Injection Adult4/9/2026For the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. 
52211595Dapagliflozin and Metformin Hydrochloride ER TabletCipla LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
51211583Dapagliflozin and Metformin Hydrochloride ER TabletTeva Pharmaceuticals USA, Inc.Xigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
50211582Dapagliflozin TabletZydus Pharmaceuticals (USA) Inc.Farxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
49211579Dapagliflozin and Metformin Hydrochloride ER TabletLupin LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
48211563Dapagliflozin and Metformin Hydrochloride ER TabletAlkem Laboratories LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
47211560Dapagliflozin TabletAlembic Pharmaceuticals LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
46211559Dapagliflozin and Metformin Hydrochloride ER TabletMacleods Pharmaceuticals LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
45211545Dapagliflozin TabletAlkem Laboratories LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
44211541Dapagliflozin TabletTeva Pharmaceuticals USA, Inc.Farxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
43211537Dapagliflozin and Saxagliptin TabletTorrent Pharmaceuticals LimitedQtern Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
42211536Dapagliflozin and Metformin Hydrochloride ER TabletCipla LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
41211535Dapagliflozin TabletCipla LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
40211533Dapagliflozin and Saxagliptin TabletMSN Laboratories Private LimitedQtern Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
39211531Dapagliflozin TabletLupin LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
38211523Dapagliflozin TabletAizant Drug Research Solutions Pvt LtdFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
37211506Dapagliflozin TabletMacleods Pharmaceuticals LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
36211491Dapagliflozin and Metformin Hydrochloride ER TabletSun Pharmaceutical Industries LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
35211489Dapagliflozin and Metformin Hydrochloride ER TabletAurobindo Pharma LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
34211482Dapagliflozin TabletAjanta Pharma LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
33211479Dapagliflozin and Metformin Hydrochloride ER TabletMSN Laboratories Private LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
32211478Dapagliflozin TabletMSN Laboratories Private LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
31211470Dapagliflozin TabletBiocon Pharma LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
30211468Dapagliflozin TabletAurobindo Pharma LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
29211467Dapagliflozin TabletMicro Labs LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
28211466Dapagliflozin and Metformin Hydrochloride ER TabletMicro Labs LimitedXigduo XR Tablet4/6/2026Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. 
27211312Dapagliflozin TabletSandoz Inc.Farxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
26211156Dapagliflozin TabletInventia Healthcare LimitedFarxiga Tablet4/6/2026Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
25214448Glycopyrronium Tosylate ClothPadagis US LLCQbrexza Cloth4/3/2026For topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
24212609Nintedanib Esylate CapsuleCipla LimitedOfev Capsule4/2/2026For the treatment of adults with idiopathic pulmonary fibrosis (IPF). 
23216915Nintedanib Esylate CapsuleSandoz Inc.Ofev Capsule4/2/2026For the treatment of adults with idiopathic pulmonary fibrosis (IPF). 
22219227Nintedanib Esylate CapsuleApotex Inc.Ofev Capsule4/2/2026For the treatment of adults with idiopathic pulmonary fibrosis (IPF). 
21219283Nintedanib Esylate CapsuleDr. Reddy's Laboratories LimitedOfev Capsule4/2/2026For the treatment of adults with idiopathic pulmonary fibrosis (IPF). 
20219819Nintedanib Esylate CapsuleDexcel Pharma Technologies Ltd.Ofev Capsule4/2/2026For the treatment of adults with idiopathic pulmonary fibrosis (IPF). 
19220483Norepinephrine Bitartrate in 5% Dextrose Injection Sagent PharmaceuticalsNorepinephrine Bitartrate in 5% Dextrose Injection 3/26/2026For restoration of blood pressure in adult patients with acute hypotensive states. 
18208959Rifaximin Tablet Actavis Laboratories FL, Inc.Xifaxan Tablet 3/19/2026For treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older. 
17219985Citalopram Hydrobromide Capsule Aurobindo Pharma LimitedCitalopram Hydrobromide Capsule 3/13/2026For treatment of Major Depressive Disorder (MDD) in adults.
16212563Ferric Citrate Tablet Teva Pharmaceuticals USA, Inc.Auryxia Tablet 3/11/2026For the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
15219997Mesalamine ER Capsule DifGen Pharmaceuticals LLCPentasa ER Capsule 3/10/2026For the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.
14218851Aprepitant Injection Mylan Pharmaceuticals Inc.Aponvie Injection 3/5/2026For the prevention of postoperative nausea and vomiting (PONV) in adults. 
13219602Fluticasone Propionate Aerosol Glenmark Specialty SAFlovent HFA Aerosol 3/3/2026For maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
12218249Brivaracetam Injection Hainan Poly Pharm. Co., LTD.Briviact Injection 2/23/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
11217953Ipratropium Bromide Aerosol Armstrong Pharmaceuticals, Inc.Atrovent HFA Aerosol 2/23/2026For maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 
10214924Brivaracetam Injection MSN Laboratories Private LimitedBriviact Injection 2/23/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
9214880Brivaracetam Injection Micro Labs LimitedBriviact Injection 2/23/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
8214922Brivaracetam Solution MSN Laboratories Private LimitedBriviact Solution 2/19/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
7216921Idelalisib Tablet Natco Pharma LimitedZydelig Tablet 2/17/2026For the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
6214095Emtricitabine, Rilpivirine and Tenofovir Alafenamide Tablet Apotex Inc.Odefsey Tablet 1/30/2026For the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
5218798Rilpivirine Tablet Somerset Therapeutics, LLCEdurant Tablet 1/29/2026For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 2 years of age and older and weighing at least 14 kg with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy in combination with other antiretroviral agents.
4214378Tapentadol Hydrochloride Tablet Humanwell Pharmaceutical US, Inc.Nucynta Tablet 1/27/2026For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg.
3219119Tapentadol Hydrochloride Solution Novitium Pharma LLCNucynta Solution 1/26/2026For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adults and pediatric patients aged 6 years and older with a body weight of at least 16 kg.
2219323Mirabegron ER, For Suspension Alkem Laboratories LimitedMyrbetriq Granules, For Suspension 1/20/2026For the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate.
1219167Bortezomib Powder, For Injection Gland Pharma LimitedBortezomib Powder, For Injection 1/6/2026For treatment of adult patients with multiple myeloma and mantle cell lymphoma.

 

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.



Back to Top