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.
- ACTAVIS LABS FL — ANDA approval: LINACLOTIDE (unspecified)
ACTAVIS LABS FL·Standard review·September 24, 2026
- NEPHRON — ANDA approval: PHENYLEPHRINE HYDROCHLORIDE (unspecified)
NEPHRON·Standard review·September 24, 2026
- ZYDUS PHARMS — ANDA approval: MEXILETINE HYDROCHLORIDE (unspecified)
ZYDUS PHARMS·Standard review·September 23, 2026
- ELEVAR THERAPEUTICS INC — NDA approval: LYRFIGTU (unspecified)
ELEVAR THERAPEUTICS INC·Priority review·September 23, 2026
- ANNORA PHARMA — ANDA approval: NORGESTIMATE AND ETHINYL ESTRADIOL (unspecified)
ANNORA PHARMA·Standard review·September 23, 2026
- ELI LILLY AND CO — BLA approval: ONSWIK (unspecified)
ELI LILLY AND CO·Standard review·September 23, 2026
- SHANDONG — ANDA approval: KETOROLAC TROMETHAMINE (unspecified)
SHANDONG·Standard review·September 23, 2026
- INVAGEN PHARMS — ANDA approval: EMPAGLIFLOZIN (unspecified)
INVAGEN PHARMS·Standard review·September 22, 2026
- SENORES PHARMS — ANDA approval: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (unspecified)
SENORES PHARMS·Standard review·September 22, 2026
- IPCA LABS LTD — ANDA approval: AMLODIPINE BESYLATE (unspecified)
IPCA LABS LTD·Standard review·September 22, 2026
- NOVITIUM PHARMA — ANDA approval: EVEROLIMUS (unspecified)
NOVITIUM PHARMA·Standard review·September 21, 2026
- LANTHEUS MEDICAL — ANDA approval: BRAVNETSA (unspecified)
LANTHEUS MEDICAL·Standard review·September 21, 2026
- BAXTER HLTHCARE CORP — ANDA approval: ROCURONIUM BROMIDE (unspecified)
BAXTER HLTHCARE CORP·Standard review·September 18, 2026
- INTRABIO — NDA approval: AQNEURSA (unspecified)
INTRABIO·Priority review·September 18, 2026
- HIKMA — ANDA approval: DEFLAZACORT (unspecified)
HIKMA·Standard review·September 18, 2026
- AMNEAL — ANDA approval: LANREOTIDE ACETATE (unspecified)
AMNEAL·Standard review·September 18, 2026
- AUROBINDO PHARMA LTD — ANDA approval: CYCLOSPORINE (unspecified)
AUROBINDO PHARMA LTD·Standard review·September 17, 2026
- CIPLA — ANDA approval: CALCIUM GLUCONATE IN SODIUM CHLORIDE (unspecified)
CIPLA·Standard review·September 17, 2026
- BAYER HLTHCARE — NDA approval: KERENDIA (unspecified)
BAYER HLTHCARE·Priority review·September 16, 2026
- DIFGEN PHARMS — ANDA approval: EPINEPHRINE (unspecified)
DIFGEN PHARMS·Standard review·September 15, 2026
- EMERGE BIOSCIENCE PTE. LTD. — BLA approval: GARZULYS (unspecified)
EMERGE BIOSCIENCE PTE. LTD.·Standard review·September 15, 2026
- STRIDES PHARMA — ANDA approval: MILNACIPRAN HYDROCHLORIDE (unspecified)
STRIDES PHARMA·Standard review·September 15, 2026
- MACLEODS PHARMS — ANDA approval: MILNACIPRAN HYDROCHLORIDE (unspecified)
MACLEODS PHARMS·Standard review·September 15, 2026
- ZYDUS LIFESCIENCES — ANDA approval: TRETINOIN (unspecified)
ZYDUS LIFESCIENCES·Standard review·September 15, 2026
- ZYDUS PHARMS — ANDA approval: EPINEPHRINE (unspecified)
ZYDUS PHARMS·Standard review·September 14, 2026

