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 2024*

	ANDA Number	Generic Name	ANDA Applicant	Brand Name	ANDA Approval Date	ANDA Indication+
37	217671	Halcinonide Topical Solution USP, 0.1%	Encube Ethicals Private Limited	Halog (Halcinonide) Topical Solution	5/29/2024	For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
36	216421	Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)	Apotex Inc.	Astepro (Azelastine Hydrochloride) Nasal Spray OTC	5/29/2024	Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
35	213682	Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg	Alembic Pharmaceuticals Limited	Entresto (Sacubitril and Valsartan ) Tablets	5/28/2024	To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older
34	213676	Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg	Laurus Labs Limited	Entresto (Sacubitril and Valsartan ) Tablets	5/28/2024	To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older
33	213605	Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg	Crystal Pharmaceutical (Suzhou) Co., Ltd.	Entresto (Sacubitril and Valsartan) Tablets	5/28/2024	To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older
32	216343	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%	Amneal EU, Limited	Timolol Maleate Ophthalmic Gel Forming Solution	5/23/2024	For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma
31	217193	Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL, Single-Dose	InvaGen Pharmaceuticals, Inc.	Somatuline Depot (Lanreotide) Injection	5/21/2024	For the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; for the treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival; for the treatment of adults with carcinoid syndrome
30	214053	Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg and 120 mg/15 mg	Apotex Inc.	Descovy (Emtricitabine and Tenofovir Alafenamide) Tablets	5/17/2024	In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg; in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg; indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP)
29	218354	Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single Dose Bags	Long Grove Pharmaceuticals, LLC	Radicava (Edaravone) Injection	5/6/2024	For the treatment of amyotrophic lateral sclerosis
28	216199	Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags	Gland Pharma Limited	Radicava (Edaravone) Injection	5/6/2024	For the treatment of amyotrophic lateral sclerosis
27	215917	Edaravone Injection, 60 mg/100 mL (0.6 mg/mL), Single-Dose Bag	Dr. Reddy's Laboratories Limited	Radicava (Edaravone) Injection	5/6/2024	For the treatment of amyotrophic lateral sclerosis
26	215508	Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single-Dose Vials	Hikma Pharmaceuticals USA, Inc.	Radicava (Edaravone) Injection	5/6/2024	For the treatment of amyotrophic lateral sclerosis
25	217791	Atropine Sulfate Ophthalmic Solution USP, 1%	Somerset Therapeutics, LLC	Isopto Atropine (Atropine Sulfate) Ophthalmic Solution	4/29/2024	Indicated for mydriasis; cycloplegia; penalization of the healthy eye in the treatment of amblyopia
24	216076	Midostaurin Capsules, 25 mg	Teva Pharmaceuticals Development, Inc	Rydapt (Midostaurin) Capsules	4/29/2024	For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive; for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia
23	217813	Deflazacort Oral Suspension, 22.75 mg/mL	Tris Pharma, Inc.	Emflaza (Deflazacort) Oral Suspension	4/25/2024	For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
22	216160	Estradiol Gel, 0.06%	Solaris Pharma Corporation	EstroGel (Estradiol) Gel	4/22/2024	For the treatment of moderate to severe vasomotor symptoms due to menopause; for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
21	216620	Eltrombopag for Oral Suspension, 12.5 mg and 25 mg	Annora Pharma Private Limited	Promacta (Eltrombopag) for Oral Suspension	4/18/2024	For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy; for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
20	203978	Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection, 40 mg/200 mL (0.2 mg/mL), Single-Dose Containers and Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL), Single-Dose Containers	InfoRLife SA	Cardene (Nicardipine Hydrochloride) I.V. Premixed injection	4/17/2024	For the short-term treatment of hypertension when oral therapy is not feasible
19	218034	Doxycycline Capsules, 40 mg	Dr. Reddy's Laboratories Limited	Oracea (Doxycycline) Capsules	4/8/2024	For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
18	216631	Doxycycline Capsules, 40 mg	Lupin, Inc.	Oracea (Doxycycline) Capsules	4/8/2024	For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
17	218047	Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-dose Vial	Gland Pharma Limited	Halaven (Eribulin Mesylate) Injection	4/5/2024	For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease; unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen
16	216064	Valbenazine Capsules, 40 mg, 60 mg, 80 mg	Lupin Limited	Ingrezza (Valbenazine) Capsules	4/5/2024	For the treatment of adults with tardive dyskinesia
15	216795	Metronidazole Vaginal Gel, 1.3%	Encube Ethicals	Nuvessa (Metronidazole) Vaginal Gel	3/18/2024	For the treatment of bacterial vaginosis in females 12 years of age and older
14	218232	Finasteride and Tadalafil Capsules, 5 mg/5 mg	Zydus Worldwide DMCC	Entadfi (Finasteride and Tadalafil) Capsules	3/15/2024	To initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks
13	216361	Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC)	Dr. Reddy's Laboratories SA	Lumify (Brimonidine Tartrate) Ophthalmic Solution	2/16/2024	Relieves redness of the eye due to minor eye irritations
12	216103	Nitroglycerin Ointment USP, 0.4%	Dr. Reddy's Laboratories SA	Rectiv (Nitroglycerin) Ointment	2/16/2024	For the treatment of moderate to severe pain associated with chronic anal fissure
11	215574	Ospemifene Tablets, 60 mg	Hetero Labs Limited Unit V	Osphena (Ospemifene) Tablets	2/13/2024	For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause; for the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause
10	217123	Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg	Aurobindo Pharma Limited	Emflaza (Deflazacort) Tablets	2/9/2024	For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
9	216899	Hydromorphone Hydrochloride Injection USP, 0.2 mg/mL, 0.5 mg/0.5 mL,1 mg/mL, 2 mg/mL Single-Dose Prefilled Syringes	Hikma Pharmaceuticals USA, Inc.	Dilaudid (Hydromorphone) Hydrochloride Injection	2/9/2024	For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
8	209986	Cobicistat Tablets, 150 mg	Mylan Laboratories Limited	Tybost (Cobicistat) Tablets	2/4/2024	For the treatment of HIV-1 infection in adults and in pediatric patients
7	211239	Bromfenac Ophthalmic Solution, 0.075%	Lupin Limited	BromSite (Bromfenac) Ophthalmic Solution	2/2/2024	For the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery
6	205904	Dronedarone Tablets USP, 400 mg	Lupin Inc.	Multaq (Dronedarone) Tablets	1/31/2024	To reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF
5	214925	Pimavanserin Capsules, 34 mg	MSN Laboratories Private Limited	Nuplazid (Pimavanserin) Capsules	1/16/2024	For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
4	214502	Pimavanserin Tablets, 10 mg	Zydus Pharmaceuticals (USA) Inc.	Nuplazid (Pimavanserin) Capsules	1/16/2024	For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
3	214493	Pimavanserin Capsules, 34 mg	Zydus Pharmaceuticals (USA) Inc.	Nuplazid (Pimavanserin) Capsules	1/16/2024	For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
2	208443	Fidaxomicin Tablets, 200 mg	Actavis Laboratories FL, Inc.	Dificid (Fidaxomicin) Tablets	1/16/2024	For the treatment of C. difficile-associated diarrhea
1	203640	Nilotinib Capsules, 50 mg, 150 mg, 200 mg	Apotex, Inc.	Tasigna (Nilotinib) Capsules	1/5/2024	For the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib; pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor therapy

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.