FDA updates labeling for REZZAYO FDA Approval Dec. 11, 2025, 09:44 UTC 41 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for MOMETASONE FUROATE FDA Approval Dec. 11, 2025, 09:44 UTC 37 0 comments Labeling changes approved for FOUGERA PHARMS. Active ingredient: MOMETASONE FUROATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for VECURONIUM BROMIDE FDA Approval Dec. 11, 2025, 09:44 UTC 50 0 comments Labeling changes approved for HIKMA. Active ingredient: VECURONIUM BROMIDE. Decision date: 12/09/2025 Comment Full text
FDA approves DOXYCYCLINE HYCLATE from MACLEODS PHARMS LTD FDA Approval Dec. 11, 2025, 09:44 UTC 37 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. 10, 2025, 19:50 UTC 41 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 10, 2025, 19:50 UTC 45 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. 10, 2025, 19:50 UTC 40 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA regulatory update for RYSTIGGO FDA Approval Dec. 10, 2025, 09:37 UTC 52 0 comments Administrative update #SUPPL-7 for UCB INC. Status: Approval. Decision date: 12/09/2025 Comment Full text
FDA expands indications for RECARBRIO FDA Approval Dec. 10, 2025, 09:37 UTC 47 0 comments MSD MERCK CO receives approval for new indications. Submission: SUPPL-8. Decision date: 12/09/2025 Comment Full text
FDA approves LINEZOLID from CAPLIN FDA Approval Dec. 10, 2025, 09:37 UTC 47 0 comments Final approval of ANDA #ANDA #219558 for LINEZOLID. Decision date: 12/08/2025 Comment Full text