FDA approves NUZOLVENCE from ENTASIS THERAP FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Final approval of NDA #NDA #219491 for ZOLIFLODACIN. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA regulatory update for UPLIZNA FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Administrative update #SUPPL-4 for VIELA BIO. Status: Approval. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for AMANTADINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for SHREE HARI INTL. Active ingredient: AMANTADINE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA approves ACETAMINOPHEN from CAPLIN FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Final approval of ANDA #ANDA #219096 for ACETAMINOPHEN. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Labeling changes approved for LANNETT CO INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/08/2025 Comment Full text
FDA approves ESTRADIOL from TEVA PHARMS USA INC FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of ANDA #ANDA #214137 for ESTRADIOL. Decision date: 12/08/2025 Comment Full text
FDA approves DOXYCYCLINE HYCLATE from MACLEODS PHARMS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Final approval of ANDA #ANDA #211137 for DOXYCYCLINE HYCLATE. Decision date: 12/09/2025 Comment Full text
FDA expands indications for RECARBRIO FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments MSD MERCK CO receives approval for new indications. Submission: SUPPL-8. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for TEPYLUTE FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for SHORLA. Active ingredient: THIOTEPA. Decision date: 12/09/2025 Comment Full text