approval database
FDA Drug Approvals
An FDA drug approval is the agency's authorization for a sponsor to market a new drug or biologic in the US, following review of safety and efficacy data. Argus HQ tracks 279 published approval submissions from 2026 to 2026, filterable by year and review pathway, each sourced from and linked back to fda.gov.
- SHANDONG — ANDA approval: SUGAMMADEX SODIUM (unspecified)
SHANDONG·Standard review·October 6, 2026
- PIRAMAL CRITICAL — ANDA approval: DESFLURANE (unspecified)
PIRAMAL CRITICAL·Standard review·October 5, 2026
- AUROBINDO PHARMA LTD — ANDA approval: PERAMPANEL (unspecified)
AUROBINDO PHARMA LTD·Standard review·October 2, 2026
- EVER VALINJECT — NDA approval: Unspecified (unspecified)
EVER VALINJECT·Standard review·October 1, 2026
- TARO — ANDA approval: LOPERAMIDE HYDROCHLORIDE (unspecified)
TARO·Standard review·September 30, 2026
- BRISTOL — NDA approval: CAMZYOS (unspecified)
BRISTOL·Priority review·September 30, 2026
- GLAND — ANDA approval: LEVOCARNITINE (unspecified)
GLAND·Standard review·September 30, 2026
- LUPIN — ANDA approval: PHYTONADIONE (unspecified)
LUPIN·Standard review·September 30, 2026
- ZYDUS LIFESCIENCES — ANDA approval: MUPIROCIN CALCIUM (unspecified)
ZYDUS LIFESCIENCES·Standard review·September 29, 2026
- UPSHER SMITH LABS — ANDA approval: PREDNISOLONE ACETATE (unspecified)
UPSHER SMITH LABS·Standard review·September 28, 2026
- RARE THYROID THERAPEUTICS INTERNATIONAL AB — NDA approval: EMCITATE (unspecified)
RARE THYROID THERAPEUTICS INTERNATIONAL AB·Priority review·September 28, 2026
- NEPHRON — ANDA approval: DEXMEDETOMIDINE HYDROCHLORIDE (unspecified)
NEPHRON·Standard review·September 28, 2026
- ADAPTIS — ANDA approval: KETOROLAC TROMETHAMINE (unspecified)
ADAPTIS·Standard review·September 25, 2026
- GENENTECH — BLA approval: GAZYVA (unspecified)
GENENTECH·Priority review·September 25, 2026
- ABBVIE INC — NDA approval: JUVMO (unspecified)
ABBVIE INC·Standard review·September 25, 2026
- YICHANG HUMANWELL — ANDA approval: DILTIAZEM HYDROCHLORIDE (unspecified)
YICHANG HUMANWELL·Standard review·September 25, 2026
- ADVENTAPHARMA DWC LLC — NDA approval: ZUEINO (unspecified)
ADVENTAPHARMA DWC LLC·Standard review·September 25, 2026
- AUROBINDO PHARMA LTD — ANDA approval: METRONIDAZOLE (unspecified)
AUROBINDO PHARMA LTD·Standard review·September 25, 2026
- AZURITY PHARMACEUTICALS INC — NDA approval: Unspecified (unspecified)
AZURITY PHARMACEUTICALS INC·Standard review·September 25, 2026
- STERISCIENCE — ANDA approval: NAFCILLIN SODIUM (unspecified)
STERISCIENCE·Standard review·September 25, 2026
- TEVA PHARMACEUTICALS, INC. — BLA approval: DEGEVMA (unspecified)
TEVA PHARMACEUTICALS, INC.·Standard review·September 25, 2026
- INCYTE CORP — NDA approval: ATEBRIOZ (unspecified)
INCYTE CORP·Priority review·September 25, 2026
- NOVITIUM PHARMA — ANDA approval: ESOMEPRAZOLE MAGNESIUM (unspecified)
NOVITIUM PHARMA·Standard review·September 25, 2026
- HONG KONG — ANDA approval: THIAMINE HYDROCHLORIDE (unspecified)
HONG KONG·Standard review·September 25, 2026
- MACLEODS PHARMS — ANDA approval: CRISABOROLE (unspecified)
MACLEODS PHARMS·Standard review·September 24, 2026

