approval database

FDA Drug Approvals

Every published FDA drug approval submission Argus has observed, filterable by year and review pathway.

• DR REDDYS — ANDA approval: PREDNISONE (unspecified)

  DR REDDYS·Standard review·June 26, 2026

• SCIEGEN PHARMS — ANDA approval: TOFACITINIB CITRATE (unspecified)

  SCIEGEN PHARMS·Standard review·June 25, 2026

• ALEMBIC — ANDA approval: DAPSONE (unspecified)

  ALEMBIC·Standard review·June 25, 2026

• MYLAN LABS LTD — ANDA approval: FERRIC CARBOXYMALTOSE (unspecified)

  MYLAN LABS LTD·Standard review·June 25, 2026

• MYLAN — ANDA approval: FERRIC CARBOXYMALTOSE (unspecified)

  MYLAN·Standard review·June 25, 2026

• MYLAN — ANDA approval: FERRIC CARBOXYMALTOSE (unspecified)

  MYLAN·Standard review·June 25, 2026

• ALEMBIC — ANDA approval: OSELTAMIVIR PHOSPHATE (unspecified)

  ALEMBIC·Standard review·June 25, 2026

• AUROBINDO PHARMA LTD — ANDA approval: ICOSAPENT ETHYL (unspecified)

  AUROBINDO PHARMA LTD·Standard review·June 24, 2026

• MICRO LABS — ANDA approval: PROPRANOLOL HYDROCHLORIDE (unspecified)

  MICRO LABS·Standard review·June 24, 2026

• AVYXA HOLDINGS — NDA approval: NAVITRUX (unspecified)

  AVYXA HOLDINGS·Standard review·June 24, 2026

• IONIS PHARMS INC — NDA approval: TRYNGOLZA (AUTOINJECTOR) (unspecified)

  IONIS PHARMS INC·Priority review·June 24, 2026

• RUBICON RESEARCH — ANDA approval: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (unspecified)

  RUBICON RESEARCH·Standard review·June 23, 2026

• MACLEODS PHARMS LTD — ANDA approval: RIFAPENTINE (unspecified)

  MACLEODS PHARMS LTD·Standard review·June 23, 2026

• MICRO LABS — ANDA approval: FLUVOXAMINE MALEATE (unspecified)

  MICRO LABS·Standard review·June 23, 2026

• ACTAVIS ELIZABETH — ANDA approval: GABAPENTIN (unspecified)

  ACTAVIS ELIZABETH·Standard review·June 23, 2026

• MACLEODS PHARMS LTD — ANDA approval: BUPROPION HYDROCHLORIDE (unspecified)

  MACLEODS PHARMS LTD·Standard review·June 23, 2026

• TEVA PHARMS INC — ANDA approval: LO JUNEL FE (unspecified)

  TEVA PHARMS INC·Standard review·June 22, 2026

• ZEALAND PHARMA — NDA approval: ZEGALOGUE (unspecified)

  ZEALAND PHARMA·Priority review·June 18, 2026

• GLAXOSMITHKLINE — NDA approval: UTEBZI (unspecified)

  GLAXOSMITHKLINE·Priority review·June 17, 2026

• ALKEM LABS LTD — ANDA approval: SOLRIAMFETOL HYDROCHLORIDE (unspecified)

  ALKEM LABS LTD·Standard review·June 17, 2026

• ACTAVIS LABS FL — ANDA approval: ELTROMBOPAG OLAMINE (unspecified)

  ACTAVIS LABS FL·Standard review·June 17, 2026

• ANNORA PHARMA — ANDA approval: FOSTAMATINIB DISODIUM (unspecified)

  ANNORA PHARMA·Standard review·June 17, 2026

• HIKMA — ANDA approval: SOLRIAMFETOL HYDROCHLORIDE (unspecified)

  HIKMA·Standard review·June 17, 2026

• NORWICH — ANDA approval: BALOXAVIR MARBOXIL (unspecified)

  NORWICH·Standard review·June 17, 2026

• ANNORA PHARMA — ANDA approval: DIPHENHYDRAMINE HYDROCHLORIDE (unspecified)

  ANNORA PHARMA·Standard review·June 17, 2026