FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 59 0 comments Labeling changes approved for HIKMA. Active ingredient: HYDROMORPHONE 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
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 54 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 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 regulatory update for HUMIRA FDA Approval Dec. 31, 2025, 13:45 UTC 50 0 comments Administrative update #SUPPL-425 for ABBVIE INC. Status: Approval. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ARYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 64 0 comments Labeling changes approved for AZURITY. Active ingredient: LISDEXAMFETAMINE DIMESYLATE. Decision date: 12/22/2025 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 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 updates labeling for OLINVYK FDA Approval Dec. 31, 2025, 13:45 UTC 62 0 comments Labeling changes approved for TREVENA. Active ingredient: OLICERIDINE. Decision date: 12/22/2025 Comment Full text
FDA approves MUCINEX 12 HR COLD & FEVER MULTI-SYMPTOM from RB HLTH FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Final approval of NDA #NDA #217338 for DEXTROMETHORPHAN/GUAIFENESIN/NAPROXEN SODIUM. Decision date: 12/22/2025 Comment Full text