FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for MACLEODS PHARMS LTD. Active ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for AUROBINDO PHARMA. Active ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Final approval of ANDA #ANDA #219727 for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves CARIPRAZINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of ANDA #ANDA #213982 for CARIPRAZINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for CLARISCAN FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Labeling changes approved for GE HEALTHCARE. Active ingredient: GADOTERATE MEGLUMINE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for TIZANIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for APOTEX INC. Active ingredient: TIZANIDINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA approves BECLOMETHASONE DIPROPIONATE from AMNEAL IRELAND LTD FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of ANDA #ANDA #213811 for BECLOMETHASONE DIPROPIONATE. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; IBUPROFEN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for ALKEM LABS LTD. Active ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA regulatory update for ENHERTU FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Administrative update #SUPPL-38 for DAIICHI SANKYO. Status: Approval. Decision date: 12/15/2025 Comment Full text