FDA updates labeling for ILLUCCIX FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for TELIX. Active ingredient: GALLIUM GA-68 GOZETOTIDE. Decision date: 12/05/2025 Comment Full text
FDA approves EPINEPHRINE from AMNEAL FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Final approval of ANDA #ANDA #218208 for EPINEPHRINE. Decision date: 12/08/2025 Comment Full text
FDA regulatory update for WINREVAIR FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Administrative update #SUPPL-8 for MERCK SHARP DOHME. Status: Approval. Decision date: 12/08/2025 Comment Full text
FDA grants tentative approval for LINAGLIPTIN from APOTEX FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Tentative approval of ANDA #ANDA #218552 for LINAGLIPTIN. Decision date: 12/08/2025 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
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for ANI PHARMS. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 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 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 updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 19 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 20 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN. Decision date: 12/09/2025 Comment Full text