FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Labeling changes approved for MYLAN. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves LOPERAMIDE HYDROCHLORIDE from AUROBINDO PHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Final approval of ANDA #ANDA #220372 for LOPERAMIDE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for METHADOSE FDA Approval Dec. 31, 2025, 13:45 UTC 55 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA approves EPOPROSTENOL SODIUM from GLAND FDA Approval Dec. 31, 2025, 13:45 UTC 38 0 comments Final approval of ANDA #ANDA #219237 for EPOPROSTENOL SODIUM. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for OTEZLA FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for AMGEN INC. Active ingredient: APREMILAST. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ORLADEYO FDA Approval Dec. 31, 2025, 13:45 UTC 61 0 comments Labeling changes approved for BIOCRYST. Active ingredient: BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA regulatory update for POMALIDOMIDE FDA Approval Dec. 31, 2025, 13:45 UTC 46 0 comments Administrative update #SUPPL-2 for HETERO LABS LTD V. Status: Approval. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 48 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 48 0 comments Final approval of ANDA #ANDA #218854 for PSEUDOEPHEDRINE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text