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.
- ZYDUS LIFESCIENCES — ANDA approval: RIFABUTIN (unspecified)
ZYDUS LIFESCIENCES·Standard review·August 21, 2026
- SOCORRO N1 — ANDA approval: NITROGLYCERIN (unspecified)
SOCORRO N1·Standard review·August 21, 2026
- ANNORA PHARMA — ANDA approval: LISINOPRIL (unspecified)
ANNORA PHARMA·Standard review·August 20, 2026
- LAURUS — ANDA approval: TICAGRELOR (unspecified)
LAURUS·Standard review·August 20, 2026
- ZYDUS PHARMS — ANDA approval: ASCORBIC ACID (unspecified)
ZYDUS PHARMS·Standard review·August 20, 2026
- REGENERON PHARMACEUTICALS, INC — BLA approval: Unspecified (unspecified)
REGENERON PHARMACEUTICALS, INC·Priority review·August 19, 2026
- BIOCON PHARMA — ANDA approval: NINTEDANIB ESYLATE (unspecified)
BIOCON PHARMA·Standard review·August 19, 2026
- EPIC PHARMA LLC — ANDA approval: RIVAROXABAN (unspecified)
EPIC PHARMA LLC·Standard review·August 19, 2026
- STERINOVA INC — ANDA approval: NALOXONE HYDROCHLORIDE (unspecified)
STERINOVA INC·Standard review·August 18, 2026
- GLENMARK PHARMS LTD — ANDA approval: FLUTICASONE PROPIONATE (unspecified)
GLENMARK PHARMS LTD·Standard review·August 18, 2026
- TEVA PHARMS USA — ANDA approval: TOFACITINIB CITRATE (unspecified)
TEVA PHARMS USA·Standard review·August 17, 2026
- JUBILANT GENERICS — ANDA approval: TADALAFIL (unspecified)
JUBILANT GENERICS·Standard review·August 17, 2026
- CREEKWOOD PHARMS — ANDA approval: PROPRANOLOL HYDROCHLORIDE (unspecified)
CREEKWOOD PHARMS·Standard review·August 14, 2026
- BAXTER HLTHCARE CORP — NDA approval: Unspecified (unspecified)
BAXTER HLTHCARE CORP·Standard review·August 14, 2026
- LUPIN LIMITED — ANDA approval: PITOLISANT (unspecified)
LUPIN LIMITED·Standard review·August 14, 2026
- MSN — ANDA approval: CABOZANTINIB S-MALATE (unspecified)
MSN·Standard review·August 14, 2026
- MSN LABORATORIES PRIVATE LTD — ANDA approval: PITOLISANT (unspecified)
MSN LABORATORIES PRIVATE LTD·Standard review·August 14, 2026
- BRISTOL MYERS SQUIBB — NDA approval: ZENBEXUS (unspecified)
BRISTOL MYERS SQUIBB·Priority review·August 13, 2026
- CERVEAU TECHNOLOGIES INC A LANTHEUS CO — NDA approval: TAUKLARIFY (unspecified)
CERVEAU TECHNOLOGIES INC A LANTHEUS CO·Standard review·August 13, 2026
- SANDOZ — ANDA approval: FIDAXOMICIN (unspecified)
SANDOZ·Standard review·August 13, 2026
- NOVITIUM PHARMA — ANDA approval: FOSFOMYCIN TROMETHAMINE (unspecified)
NOVITIUM PHARMA·Standard review·August 12, 2026
- AUROBINDO PHARMA LTD — ANDA approval: TRIAMCINOLONE ACETONIDE (unspecified)
AUROBINDO PHARMA LTD·Standard review·August 11, 2026
- HUAREN PHARMACEUTICAL CO LTD — ANDA approval: VALSARTAN (unspecified)
HUAREN PHARMACEUTICAL CO LTD·Standard review·August 11, 2026
- AUROBINDO PHARMA — ANDA approval: BRIVARACETAM (unspecified)
AUROBINDO PHARMA·Standard review·August 10, 2026
- VIWIT PHARM — ANDA approval: GADOTERATE MEGLUMINE (unspecified)
VIWIT PHARM·Standard review·August 10, 2026

