Drugs · openFDA

Approvals (Drugs@FDA)

Every FDA-approved drug and biologic application: sponsor, products, strengths and marketing status. 29,457 records; openFDA updated it 2026-11-13. About this dataset

Records

WARFARIN SODIUM
WATSON LABS · WARFARIN SODIUM
ANDA086118Generic (ANDA)Discontinued
FDA page
IMIPRAMINE HYDROCHLORIDE
NOVARTIS · IMIPRAMINE HYDROCHLORIDE
ANDA086765Generic (ANDA)Discontinued
FDA page
THALITONE
MONARCH PHARMS · CHLORTHALIDONE
2005-10-27ANDA088051Generic (ANDA)Discontinued
FDA page
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE · CYCLOPHOSPHAMIDE
1991-12-03ANDA088372Generic (ANDA)Discontinued
FDA page
AMITRIPTYLINE HYDROCHLORIDE
PAR PHARM · AMITRIPTYLINE HYDROCHLORIDE
1984-09-25ANDA088699Generic (ANDA)Discontinued
FDA page
HYDROXYZINE PAMOATE
SUPERPHARM · HYDROXYZINE PAMOATE
1989-10-06ANDA089031Generic (ANDA)Discontinued
FDA page
AMITRIPTYLINE HYDROCHLORIDE
MUTUAL PHARM · AMITRIPTYLINE HYDROCHLORIDE
2007-11-21ANDA089400Generic (ANDA)Prescription
FDA page
METHYCLOTHIAZIDE
CHARTWELL RX · METHYCLOTHIAZIDE
2001-05-09ANDA089837Generic (ANDA)Discontinued
FDA page
DONEPEZIL HYDROCHLORIDE
AIPING PHARM INC · DONEPEZIL HYDROCHLORIDE
2019-05-21ANDA090290Generic (ANDA)Discontinued
FDA page
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
SANDOZ · DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
2021-03-16ANDA090604Generic (ANDA)Prescription
FDA page
SUMATRIPTAN; NAPROXEN SODIUM
DR REDDYS LABS LTD · SUMATRIPTAN, NAPROXEN SODIUM
2011-01-20ANDA090930Generic (ANDA)None (Tentative Approval)
FDA page
DOXYCYCLINE
LUPIN LTD · DOXYCYCLINE
2013-07-29ANDA091277Generic (ANDA)None (Tentative Approval)
FDA page
TRAMADOL HYDROCHLORIDE
ACTAVIS ELIZABETH · TRAMADOL HYDROCHLORIDE
2026-06-18ANDA091609Generic (ANDA)Discontinued
FDA page
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANI PHARMS · AMOXICILLIN, CLARITHROMYCIN, LANSOPRAZOLE
2024-05-01ANDA200218Generic (ANDA)Discontinued
FDA page
SEVELAMER CARBONATE
STRIDES PHARMA INTL · SEVELAMER CARBONATE
2020-08-05ANDA201069Generic (ANDA)Discontinued
FDA page
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
MACLEODS PHARMS LTD · HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM
2026-02-17ANDA202289Generic (ANDA)Prescription
FDA page
ISMO
PROMIUS PHARMA · ISOSORBIDE MONONITRATE
2000-06-13NDA019091Drug (NDA)Discontinued
FDA page
VYFEMLA
LUPIN · ETHINYL ESTRADIOL, NORETHINDRONE
2022-04-29ANDA201886Generic (ANDA)Prescription
FDA page
LIDOCAINE
AMNEAL · LIDOCAINE
2020-08-24ANDA206463Generic (ANDA)Prescription
FDA page
ENTECAVIR
CIPLA · ENTECAVIR
2020-06-18ANDA206872Generic (ANDA)Prescription
FDA page

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.