FDA updates labeling for REZZAYO FDA Approval Dec. 11, 2025, 09:44 UTC 55 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 52 0 comments Labeling changes approved for FOUGERA PHARMS. Active ingredient: MOMETASONE FUROATE. Decision date: 12/10/2025 Comment Full text
FDA approves DOXYCYCLINE HYCLATE from MACLEODS PHARMS LTD FDA Approval Dec. 11, 2025, 09:44 UTC 47 0 comments Final approval of ANDA #ANDA #211137 for DOXYCYCLINE HYCLATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for VECURONIUM BROMIDE FDA Approval Dec. 11, 2025, 09:44 UTC 69 0 comments Labeling changes approved for HIKMA. Active ingredient: VECURONIUM BROMIDE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 10, 2025, 19:50 UTC 56 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 56 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 63 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 75 0 comments Administrative update #SUPPL-7 for UCB INC. Status: Approval. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 10, 2025, 09:37 UTC 71 0 comments Labeling changes approved for HIBROW HLTHCARE. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA approves ESTRADIOL from TEVA PHARMS USA INC FDA Approval Dec. 10, 2025, 09:37 UTC 58 0 comments Final approval of ANDA #ANDA #214137 for ESTRADIOL. Decision date: 12/08/2025 Comment Full text