FDA updates labeling for HYCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Labeling changes approved for GENUS. Active ingredient: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PERCOCET FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for ENDO OPERATIONS. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA approves JASCAYD from BOEHRINGER INGELHEIM FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Final approval of NDA #NDA #220449 for NERANDOMILAST. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for REZDIFFRA FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for MADRIGAL. Active ingredient: RESMETIROM. Decision date: 12/19/2025 Comment Full text
FDA approves DECITABINE from RELIANCE LIFE SCI FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Final approval of ANDA #ANDA #217814 for DECITABINE. Decision date: 12/19/2025 Comment Full text
FDA regulatory update for LUNSUMIO FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Administrative update #SUPPL-6 for GENENTECH INC. Status: Approval. Decision date: 12/19/2025 Comment Full text
FDA expands indications for MOUNJARO FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments ELI LILLY AND CO receives approval for new indications. Submission: SUPPL-39. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Labeling changes approved for CHARTWELL. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for STRIDES PHARMA INTL. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text