FDA First Generic Drug Approvals 2025

Jan 14 , 2026

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 2025*

	ANDA Number	Generic Name	ANDA Applicant	Brand Name	ANDA Approval Date	ANDA Indication+
87	214137	Estradiol Vaginal Insert	Teva Pharmaceuticals USA, Inc.	Imvexxy Vaginal Insert	12/8/2025	For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
86	202388	Sitagliptin and Metformin Hydrochloride Tablet	Sandoz Inc.	Janumet Tablet	12/2/2025	Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
85	218425	Cladribine Tablet	Apotex Inc.	Mavenclad Tablet	11/24/2025	For the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults.
84	220043	Voriconazole Injection	Hainan Poly Pharm. Co., Ltd.	Vfend Injection	11/14/2025	For the treatment of invasive aspergillosis (IA) in adults and pediatric patients (2 years of age and older).
83	217468	Diazepam Rectal Gel Delivery System	Navinta LLC	Diastat and Diastat Acudial Rectal Gel	11/14/2025	For the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.
82	217737	Iohexol Injection	Amneal EU, Limited	Omnipaque Injection	11/13/2025	For myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older.
81	218596	Diroximel Fumarate Delayed-Release Capsule	Zydus Worldwide DMCC	Vumerity Delayed-Release Capsule	11/12/2025	For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
80	218273	Ciprofloxacin Hydrochloride and Hydrocortisone Suspension/Drop	Cosette Pharmaceuticals NC Laboratories, LLC	Cipro HC Suspension/Drop	11/10/2025	For the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis.
79	211650	Axitinib Tablet	Apotex Inc.	Inlyta Tablet	10/30/2025	For the first-line treatment of patients with advanced renal cell carcinoma (RCC) in combination with avelumab.
78	218031	Drospirenone and Estradiol Tablet	Novast Laboratories Ltd.	Angeliq Tablet	10/28/2025	For the treatment of moderate to severe vasomotor symptoms due to menopause and for moderate to severe vulvar and vaginal atrophy symptoms due to menopause.
77	219265	Lomustine Capsule	Carnegie Pharmaceuticals LLC	Gleostine Capsule	10/27/2025	For the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
76	219465	Dalbavancin Hydrochloride Powder, For Injection	Teva Pharmaceuticals, Inc.	Dalvance Powder, For Injection	10/23/2025	For the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible isolates).
75	218845	Gallium Ga 68 Edotreotide Injection	The Methodist Hospital Research Institute	Gallium Ga 68 Edotreotide Injection	10/10/2025	For use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

74	218391	Progesterone Vaginal Insert	Xiromed Pharma Espana, S.L.	Endometrin Vaginal Insert	9/19/2025	Indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
73	219684	Ketamine Hydrochloride Injection	Baxter Healthcare Corporation	Ketalar Injection	9/17/2025	Indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
72	219922	Pazopanib Hydrochloride Tablet	Torrent Pharmaceuticals Limited	Votrient Tablet	9/4/2025	For the treatment of adults with advanced renal cell carcinoma (RCC).
71	214568	Liraglutide Injection	Teva Pharmaceuticals Development, Inc.	Saxenda Injection	8/27/2025	For use in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity and overweight adults in the presence of at least one weight-related comorbid condition.
70	219692	Norepinephrine Bitartrate in 5% Dextrose Injection	Sagent Pharmaceuticals	Norepinephrine Bitartrate in 5% Dextrose Injection	8/11/2025	Indicated to raise blood pressure in adult patients with severe, acute hypotension.
69	213551	Cangrelor Powder, For Injection	Gland Pharma Limited	Kengreal Powder, For Injection	8/11/2025	Indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
68	208977	Iron Sucrose Injection	International Medication Systems, Limited	Venofer Injection	8/8/2025	For the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
67	212340	Iron Sucrose Injection	Sandoz Inc.	Venofer Injection	8/8/2025	For the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
66	212559	Iron Sucrose Injection	Mylan Laboratories Limited	Venofer Injection	8/8/2025	For the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
65	217585	Baricitinib Tablet	MSN Laboratories Private Limited	Olumiant Tablet	8/8/2025	For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
64	217131	Ascorbic Acid Injection	Fresenius Kabi USA, LLC	Ascor Injection	8/7/2025	For the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
63	215393	Tazarotene Lotion	Padagis Israel Pharmaceuticals Ltd.	Arazlo Lotion	7/29/2025	For the topical treatment of acne vulgaris in patients 9 years of age and older.
62	202136	Darunavir Tablet	Mylan Pharmaceuticals Inc.	Prezista Tablet	7/22/2025	For the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older, co-administered with ritonavir (Prezista/ritonavir) and with other antiretroviral agents.
61	218853	Sertraline Hydrochloride Capsule	Zenara Pharma Private Limited	Sertraline Hydrochloride Capsule	7/16/2025	For the treatment of major depressive disorder (MDD) in adults.
60	218152	Perampanel Suspension	MSN Laboratories Private Limited	Fycompa Suspension	7/11/2025	For treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.
59	217583	Manganese Chloride Injection	Fresenius Kabi USA, LLC	Manganese Chloride in Plastic Container	7/7/2025	Indicated in adult patients as a supplement to intravenous solutions given for TPN.
58	218087	Loteprednol Etabonate Gel	Lupin Limited	Lotemax SM Gel	6/30/2025	For the treatment of postoperative inflammation and pain following ocular surgery.
57	218502	Rivaroxaban Granule, For Suspension	Alkem Laboratories Limited	Xarelto Granule, For Suspension	6/26/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
56	217845	Dehydrated Alcohol Injection	Accord Healthcare Inc.	Ablysinol Injection	6/23/2025	To induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.
55	219084	Meropenem Powder, For Injection	Brooks Steriscience Limited	Meropenem Powder, For Injection	6/23/2025	For the treatment of bacterial meningitis in pediatric patients 3 months of age and older only.
54	219400	Dehydrated Alcohol Injection	XGen Pharmaceuticals DJB, Inc.	Ablysinol Injection	6/23/2025	To induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.
53	219444	Dehydrated Alcohol Injection	Breckenridge Pharmaceutical, Inc.	Ablysinol Injection	6/23/2025	To induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.
52	219633	Selenious Acid Injection	Aspiro Pharma Limited	Selenious Acid Injection	6/11/2025	Indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
51	204144	Sitagliptin and Metformin ER Tablet	PH Health Limited	Janumet XR Tablet	6/4/2025	Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
50	216966	Angiotensin II Acetate Injection	Gland Pharma Limited	Giapreza Injection	6/3/2025	To increase blood pressure in adults with septic or other distributive shock.
49	208592	Methylnaltrexone Bromide Injection	Mylan Laboratories Limited	Relistor Injection	5/28/2025	For the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
48	219777	Magnesium Sulfate Injection	Aspiro Pharma Limited	Magnesium Sulfate Injection	5/28/2025	For replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia.
47	209543	Bosutinib Monohydrate Tablet	Alembic Pharmaceuticals Limited	Bosulif Tablet	5/23/2025	For 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.
46	209801	Perampanel Tablet	Teva Pharmaceuticals USA, Inc.	Fycompa Tablet	5/23/2025	For the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.
45	208452	Emtricitabine, Rilpivirine and Tenofovir Disoproxil Fumarate Tablet	Mylan Pharmaceuticals Inc.	Complera Tablet	5/20/2025	Indicated for use as a complete regimen for the treatment of HIV-1 infection in (1) patients 12 years of age and older with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and (2) in certain virologically-suppressed (HIV-1 RNA < 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen.
44	208534	Rivaroxaban Tablet	Dr. Reddy's Laboratories Limited	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
43	208543	Rivaroxaban Tablet	InvaGen Pharmaceuticals, Inc.	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
42	208555	Rivaroxaban Tablet	Lupin Limited	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
41	210301	Rivaroxaban Tablet	Alembic Pharmaceuticals Limited	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
40	213114	Rivaroxaban Tablet	Macleods Pharmaceuticals Limited	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
39	213348	Rivaroxaban Tablet	Sunshine Lake Pharma Co., Ltd.	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
38	216995	Rivaroxaban Tablet	AiPing Pharmaceutical, Inc.	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
37	218107	Rivaroxaban Tablet	Biocon Pharma Limited	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.

36	219332	Rivaroxaban Tablet	Ascent Pharmaceuticals Inc.	Xarelto Tablet	5/14/2025	To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
35	217990	Raltegravir Potassium Tablet	Lupin Limited	Isentress HD Tablet	5/6/2025	For the treatment of human immunodeficiency virus (HIV-1) infection in adult patients in combination with other antiretroviral agents.
34	217190	Halobetasol Propionate and Tazarotene Lotion	Sun Pharma Canada Inc.	Duobrii Lotion	5/2/2025	For the topical treatment of plaque psoriasis in adults.
33	218454	Midazolam in 0.8% Sodium Chloride Injection	B. Braun Medical Inc.	Midazolam in 0.8% Sodium Chloride Injection	5/1/2025	For sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting via continuous intravenous infusion.
32	217387	Latanoprostene Bunod Solution/Drop	Gland Pharma Limited	Vyzulta Solution/Drop	4/29/2025	For the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
31	217733	Pilocarpine Hydrochloride Solution/Drop	Amneal EU, Limited	Vuity Solution/Drop	4/28/2025	For the treatment of presbyopia in adults.
30	216719	Naloxone Hydrochloride Nasal Spray	Padagis Israel Pharmaceuticals Ltd	Kloxxado Nasal Spray	4/24/2025	For the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.
29	216063	Tolvaptan Tablet	Lupin Limited	Jynarque Tablet	4/23/2025	To slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
28	218444	Siponimod Tablet	RiconPharma LLC	Mayzent Tablet	4/22/2025	For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
27	218235	Nitroglycerin Ointment	Encube Ethicals Private Limited	Nitroglycerin Ointment	4/15/2025	For the prevention of angina pectoris due to coronary artery disease.
26	219215	Acetaminophen Injection	Gland Pharma Limited	Acetaminophen Injection	4/2/2025	For management of mild to moderate pain in adult and pediatric patients 2 years and older.

25	215146	Technetium TC-99M Pentetate Acid Kit Injection	Curium US LLC	Drazimage DTPA Kit Injection	3/26/2025	For brain imaging in adults.
24	217221	Lidocaine Patch	Aveva Drug Delivery Systems, Inc.	Ztlido Patch	3/25/2025	For relief of pain associated with post-herpetic neuralgia (PHN) in adults.
23	217113	Apalutamide Tablet	Zydus Worldwide DMCC	Erleada Tablet	3/17/2025	For the treatment of patients with metastatic castration-sensative prostate cancer and non-metastatic castration-resistant prostate cancer.
22	218196	Bimatoprost Drops	Mankind Pharma Limited	Lumigan Drops	3/17/2025	For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
21	213522	Eluxadoline Tablet	Zydus Pharmaceuticals (USA) Inc.	Viberzi Tablet	3/14/2025	For the treatment of irritable bowel syndrome with diarrhea (IBS-D).
20	218628	Buspirone Hydrochloride Capsule	Pangea Pharmaceuticals LLC	Buspar Capsule	3/13/2025	For the management of anxiety disorders or the short-term relief of the symptoms of anxiety.
19	216125	Fludeoxyglucose F-18 Injection	BAMF Health Inc.	Fludeoxyglucose F18 Injection	3/11/2025	For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
18	206183	Pralatrexate Injection	Dr. Reddy's Laboratories Limited	Folotyn Injection	3/10/2025	For the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
17	208555	Rivaroxaban Tablet	Lupin Limited	Xarelto Tablet	3/3/2025	For indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
16	208557	Rivaroxaban Tablet	Taro Pharmaceutical Industries Ltd.	Xarelto Tablet	3/3/2025	For indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
15	216418	Mercaptopurine Suspension	Hikma Pharmaceuticals USA Inc.	Purixan Suspension	2/26/2025	For the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
14	215617	Phenylephrine Hydrochloride Injection	Somerset Therapeutics, LLC	Biorphen Injection	2/14/2025	For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
13	218749	Gadoteridol Injection	Hainan Poly Pharm. Co., Ltd.	Prohance Injection	2/11/2025	For indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates.
12	218779	Selenious Acid Injection	Fresenius Kabi USA, LLC	Selenious Acid Injection	2/10/2025	For indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
11	219239	Epinephrine Injection	Gland Pharma Limited	Epinephrine Injection	2/6/2025	For indicated to increase mean arterial blood pressure in adult patients with hypotension asociated with septic shock.
10	213154	Bosentan Tablet, For Suspension	Natco Pharma Limited	Tracleer Tablet, For Suspension	2/5/2025	For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-toright shunts (18%).
9	215922	Ivermectin Tablet	Rubicon Research Private Limited	Stromectol Tablet	1/22/2025	For the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis.
8	213409	Nimodipine Solution	Alkem Laboratories Limited	Nymalize Solution	1/22/2025	For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
7	217490	Azilsartan Medoxomil and Chlorthalidone Tablet	Alkem Laboratories Limited	Edarbyclor Tablet	1/21/2025	For the treatment of hypertension, to lower blood pressure.
6	206788	Eltrombopag Olamine Tablet	Hetero Labs Limited Unit V	Promacta Tablet	1/17/2025	For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
5	218211	Ephedrine Sulfate Injection	Gland Pharma Limited	Emerphed Injection	1/16/2025	For the treatment of clinically important hypotension occurring in the setting of anesthesia.
4	218871	Mesna Tablet	Novast Laboratories Limited	Mesnex Tablet	1/13/2025	For prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
3	209728	Regorafenib Tablet	Teva Pharmaceuticals USA	Stivarga Tablet	1/13/2025	For the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
2	217714	Esomeprazole Magnesium For Suspension	Cipla Limited	Nexium For Suspension	1/7/2025	For short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.
1	214966	Phytonadione Injection	Cipla Limited	Phytonadione Injection	1/3/2025	For the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by viamin K-deficiency or interference with vitamin K activity: anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives.

Soure from FDA

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