enforcement database
FDA ANDA Approvals
212 documented actions on record. Abbreviated New Drug Application approvals -- generic drug approvals granted by the FDA.
- Total actions
- 212
- Earliest on record
- June 9, 2026
- Most recent
- October 8, 2026
- Source
- openFDA (approval)
Severity breakdown
- Informational212
Most recent anda approvals (30 of 212 shown)
- ANNORA PHARMA PRIVATE LIMITED — ANDA approval: PITOLISANT (unspecified)
October 8, 2026·Informational
- HIKMA — ANDA approval: FIDAXOMICIN (unspecified)
October 7, 2026·Informational
- RUBICON RESEARCH — ANDA approval: HYDROCHLOROTHIAZIDE (unspecified)
October 7, 2026·Informational
- CREEKWOOD PHARMS — ANDA approval: MIRABEGRON (unspecified)
October 7, 2026·Informational
- AUROBINDO PHARMA LTD — ANDA approval: SOLRIAMFETOL (unspecified)
October 6, 2026·Informational
- SHANDONG — ANDA approval: SUGAMMADEX SODIUM (unspecified)
October 6, 2026·Informational
- PIRAMAL CRITICAL — ANDA approval: DESFLURANE (unspecified)
October 5, 2026·Informational
- AUROBINDO PHARMA LTD — ANDA approval: PERAMPANEL (unspecified)
October 2, 2026·Informational
- TARO — ANDA approval: LOPERAMIDE HYDROCHLORIDE (unspecified)
September 30, 2026·Informational
- LUPIN — ANDA approval: PHYTONADIONE (unspecified)
September 30, 2026·Informational
- GLAND — ANDA approval: LEVOCARNITINE (unspecified)
September 30, 2026·Informational
- ZYDUS LIFESCIENCES — ANDA approval: MUPIROCIN CALCIUM (unspecified)
September 29, 2026·Informational
- UPSHER SMITH LABS — ANDA approval: PREDNISOLONE ACETATE (unspecified)
September 28, 2026·Informational
- NEPHRON — ANDA approval: DEXMEDETOMIDINE HYDROCHLORIDE (unspecified)
September 28, 2026·Informational
- AUROBINDO PHARMA LTD — ANDA approval: METRONIDAZOLE (unspecified)
September 25, 2026·Informational
- HONG KONG — ANDA approval: THIAMINE HYDROCHLORIDE (unspecified)
September 25, 2026·Informational
- NOVITIUM PHARMA — ANDA approval: ESOMEPRAZOLE MAGNESIUM (unspecified)
September 25, 2026·Informational
- STERISCIENCE — ANDA approval: NAFCILLIN SODIUM (unspecified)
September 25, 2026·Informational
- ADAPTIS — ANDA approval: KETOROLAC TROMETHAMINE (unspecified)
September 25, 2026·Informational
- YICHANG HUMANWELL — ANDA approval: DILTIAZEM HYDROCHLORIDE (unspecified)
September 25, 2026·Informational
- MACLEODS PHARMS — ANDA approval: CRISABOROLE (unspecified)
September 24, 2026·Informational
- NEPHRON — ANDA approval: PHENYLEPHRINE HYDROCHLORIDE (unspecified)
September 24, 2026·Informational
- ACTAVIS LABS FL — ANDA approval: LINACLOTIDE (unspecified)
September 24, 2026·Informational
- ANNORA PHARMA — ANDA approval: NORGESTIMATE AND ETHINYL ESTRADIOL (unspecified)
September 23, 2026·Informational
- ZYDUS PHARMS — ANDA approval: MEXILETINE HYDROCHLORIDE (unspecified)
September 23, 2026·Informational
- SHANDONG — ANDA approval: KETOROLAC TROMETHAMINE (unspecified)
September 23, 2026·Informational
- INVAGEN PHARMS — ANDA approval: EMPAGLIFLOZIN (unspecified)
September 22, 2026·Informational
- SENORES PHARMS — ANDA approval: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (unspecified)
September 22, 2026·Informational
- IPCA LABS LTD — ANDA approval: AMLODIPINE BESYLATE (unspecified)
September 22, 2026·Informational
- NOVITIUM PHARMA — ANDA approval: EVEROLIMUS (unspecified)
September 21, 2026·Informational
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.