FDA approves OMEPRAZOLE AND SODIUM BICARBONATE from NOVITIUM PHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Final approval of ANDA #ANDA #219161 for OMEPRAZOLE; SODIUM BICARBONATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Labeling changes approved for SUN PHARM INDS LTD. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves NUZOLVENCE from ENTASIS THERAP FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Final approval of NDA #NDA #219491 for ZOLIFLODACIN. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for ARIKAYCE KIT FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for INSMED INC. Active ingredient: AMIKACIN SULFATE. Decision date: 12/05/2025 Comment Full text
FDA approves ESTRADIOL from TEVA PHARMS USA INC FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Final approval of ANDA #ANDA #214137 for ESTRADIOL. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for HIBROW HLTHCARE. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for VECURONIUM BROMIDE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for HIKMA. Active ingredient: VECURONIUM BROMIDE. Decision date: 12/09/2025 Comment Full text
FDA expands indications for RECARBRIO FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments MSD MERCK CO receives approval for new indications. Submission: SUPPL-8. Decision date: 12/09/2025 Comment Full text