FDA approves LOPINAVIR AND RITONAVIR from MICRO LABS FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Final approval of ANDA #ANDA #214696 for LOPINAVIR; RITONAVIR. Decision date: 12/11/2025 Comment Full text
FDA approves NOREPINEPHRINE BITARTRATE from MSN FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Final approval of ANDA #ANDA #218595 for NOREPINEPHRINE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA regulatory update for STEQEYMA FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Administrative update #SUPPL-7 for CELLTRION, INC.. Status: Approval. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for SULFAMETHOPRIM-DS FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for NOVEL LABS INC. Active ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for THALLOUS CHLORIDE TL 201 FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for CURIUM. Active ingredient: THALLOUS CHLORIDE TL-201. Decision date: 12/10/2025 Comment Full text
FDA regulatory update for ILUMYA FDA Approval Dec. 31, 2025, 13:45 UTC 13 0 comments Administrative update #SUPPL-24 for SUN PHARMA GLOBAL. Status: Approval. Decision date: 12/12/2025 Comment Full text
FDA approves LEROCHOL from LIB THERAPEUTICS, INC. FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Final approval of BLA #BLA #761427 for LERODALCIBEP-LIGA. Decision date: 12/12/2025 Comment Full text
FDA approves NUZOLVENCE from ENTASIS THERAP FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Final approval of NDA #NDA #219491 for ZOLIFLODACIN. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for REZZAYO FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for ALKEM LABS LTD. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text