FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 91 0 comments Labeling changes approved for HIKMA. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for HUMIRA FDA Approval Dec. 31, 2025, 13:45 UTC 69 0 comments Administrative update #SUPPL-425 for ABBVIE INC. Status: Approval. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 84 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OLINVYK FDA Approval Dec. 31, 2025, 13:45 UTC 94 0 comments Labeling changes approved for TREVENA. Active ingredient: OLICERIDINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ARYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 100 0 comments Labeling changes approved for AZURITY. Active ingredient: LISDEXAMFETAMINE DIMESYLATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 89 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ORLADEYO FDA Approval Dec. 31, 2025, 13:45 UTC 99 0 comments Labeling changes approved for BIOCRYST. Active ingredient: BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from JIANGSU HANSOH PHARM FDA Approval Dec. 31, 2025, 13:45 UTC 89 0 comments Tentative approval of ANDA #ANDA #216119 for DAPAGLIFLOZIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 79 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves PSEUDOEPHEDRINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 88 0 comments Final approval of ANDA #ANDA #218854 for PSEUDOEPHEDRINE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text