FDA approves LOTEPREDNOL ETABONATE AND TOBRAMYCIN from ALEMBIC FDA Approval Dec. 12, 2025, 05:09 UTC 0 0 comments Final approval of ANDA #ANDA #217597 for LOTEPREDNOL ETABONATE; TOBRAMYCIN. Decision date: 12/10/2025 Comment Full text
FDA approves ISOPROTERENOL HYDROCHLORIDE from DEVA HOLDING AS FDA Approval Dec. 12, 2025, 05:09 UTC 2 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. 11, 2025, 09:44 UTC 0 0 comments Labeling changes approved for FOUGERA PHARMS. Active ingredient: MOMETASONE FUROATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for THALLOUS CHLORIDE TL 201 FDA Approval Dec. 11, 2025, 09:44 UTC 0 0 comments Labeling changes approved for CURIUM. Active ingredient: THALLOUS CHLORIDE TL-201. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for VECURONIUM BROMIDE FDA Approval Dec. 11, 2025, 09:44 UTC 2 0 comments Labeling changes approved for HIKMA. Active ingredient: VECURONIUM BROMIDE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for REZZAYO FDA Approval Dec. 11, 2025, 09:44 UTC 0 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text
FDA approves DOXYCYCLINE HYCLATE from MACLEODS PHARMS LTD FDA Approval Dec. 11, 2025, 09:44 UTC 0 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 3 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 1 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 1 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN. Decision date: 12/09/2025 Comment Full text