FDA grants tentative approval for RIFAXIMIN from CIPLA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Tentative approval of ANDA #ANDA #219570 for RIFAXIMIN. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for PHARM ASSOC. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for HIBROW HLTHCARE. Active ingredient: OXYCODONE 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 32 0 comments Final approval of ANDA #ANDA #211137 for DOXYCYCLINE HYCLATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for HIKMA. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA regulatory update for WINREVAIR FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Administrative update #SUPPL-8 for MERCK SHARP DOHME. Status: Approval. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for CHARTWELL MOLECULAR. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 27 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. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA approves EPINEPHRINE from AMNEAL FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Final approval of ANDA #ANDA #218208 for EPINEPHRINE. Decision date: 12/08/2025 Comment Full text