FDA approves ISOPROTERENOL HYDROCHLORIDE from DEVA HOLDING AS FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of ANDA #ANDA #213305 for ISOPROTERENOL HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for MOMETASONE FUROATE FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for FOUGERA PHARMS. Active ingredient: MOMETASONE FUROATE. Decision date: 12/10/2025 Comment Full text
FDA approves TERIPARATIDE from AMPHASTAR PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Final approval of ANDA #ANDA #213641 for TERIPARATIDE. Decision date: 12/12/2025 Comment Full text
FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA regulatory update for ACTEMRA FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Administrative update #SUPPL-59 for GENENTECH. Status: Approval. Decision date: 12/10/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from SPECGX LLC FDA Approval Dec. 31, 2025, 13:45 UTC 14 0 comments Final approval of ANDA #ANDA #218473 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA approves DAYBUE STIX from ACADIA PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of NDA #NDA #219884 for TROFINETIDE. Decision date: 12/11/2025 Comment Full text
FDA approves DEFERIPRONE from SENORES PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Final approval of ANDA #ANDA #220132 for DEFERIPRONE. Decision date: 12/11/2025 Comment Full text
FDA approves NOREPINEPHRINE BITARTRATE from MSN FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of ANDA #ANDA #218595 for NOREPINEPHRINE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/11/2025 Comment Full text