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 187 published approval submissions from 2026 to 2026, filterable by year and review pathway, each sourced from and linked back to fda.gov.
- AUROBINDO PHARMA — ANDA approval: VANCOMYCIN HYDROCHLORIDE (unspecified)
AUROBINDO PHARMA·Standard review·August 7, 2026
- LUPIN — ANDA approval: SODIUM ZIRCONIUM CYCLOSILICATE (unspecified)
LUPIN·Standard review·August 7, 2026
- BAXTER HLTHCARE CORP — ANDA approval: LEVETIRACETAM (unspecified)
BAXTER HLTHCARE CORP·Standard review·August 6, 2026
- DR REDDYS — ANDA approval: LORATADINE AND PSEUDOEPHEDRINE SULFATE (unspecified)
DR REDDYS·Standard review·August 6, 2026
- UMEDICA — ANDA approval: RANOLAZINE (unspecified)
UMEDICA·Standard review·August 5, 2026
- TAKEDA PHARMS USA — NDA approval: ORZEYFUL (unspecified)
TAKEDA PHARMS USA·Priority review·August 5, 2026
- AUROBINDO PHARMA — ANDA approval: ESLICARBAZEPINE ACETATE (unspecified)
AUROBINDO PHARMA·Standard review·August 5, 2026
- FRESENIUS KABI USA — ANDA approval: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (unspecified)
FRESENIUS KABI USA·Standard review·August 4, 2026
- UMEDICA — ANDA approval: SACUBITRIL AND VALSARTAN (unspecified)
UMEDICA·Standard review·August 4, 2026
- MACLEODS PHARMS LTD — ANDA approval: NINTEDANIB ESYLATE (unspecified)
MACLEODS PHARMS LTD·Standard review·August 3, 2026
- ZYDUS LIFESCIENCES — ANDA approval: INDOCYANINE GREEN (unspecified)
ZYDUS LIFESCIENCES·Standard review·August 3, 2026
- MANKIND PHARMA — ANDA approval: THIAMINE HYDROCHLORIDE (unspecified)
MANKIND PHARMA·Standard review·July 31, 2026
- KLM LABS PVT — ANDA approval: DOCOSANOL (unspecified)
KLM LABS PVT·Standard review·July 31, 2026
- DR REDDYS LABS SA — BLA approval: Unspecified (unspecified)
DR REDDYS LABS SA·Standard review·July 31, 2026
- GLAND — ANDA approval: ATROPINE SULFATE (unspecified)
GLAND·Standard review·July 31, 2026
- DEVA HLDING — ANDA approval: EPINEPHRINE (unspecified)
DEVA HLDING·Standard review·July 31, 2026
- STIRA — ANDA approval: ASCORBIC ACID (unspecified)
STIRA·Standard review·July 30, 2026
- DR REDDYS — ANDA approval: FEXOFENADINE HYDROCHLORIDE (unspecified)
DR REDDYS·Standard review·July 30, 2026
- INNOGENIX INC — ANDA approval: DOFETILIDE (unspecified)
INNOGENIX INC·Standard review·July 29, 2026
- LNK INTL INC — ANDA approval: POLYETHYLENE GLYCOL 3350 (unspecified)
LNK INTL INC·Standard review·July 29, 2026
- CMP DEV LLC — NDA approval: QLONILIK (unspecified)
CMP DEV LLC·Standard review·July 29, 2026
- FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified)
FRESENIUS KABI USA LLC·Standard review·July 29, 2026
- QILU PHARM HAINAN — ANDA approval: SUGAMMADEX SODIUM (unspecified)
QILU PHARM HAINAN·Standard review·July 28, 2026
- ESJAY PHARMA — ANDA approval: GLYCEROL PHENYLBUTYRATE (unspecified)
ESJAY PHARMA·Standard review·July 28, 2026
- SUN PHARM INDS INC — ANDA approval: SUGAMMADEX SODIUM (unspecified)
SUN PHARM INDS INC·Standard review·July 28, 2026

