FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for SUN PHARM INDS INC. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for TEVA. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for WATSON LABS. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for SUN PHARM INDS LTD. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves NUZOLVENCE from ENTASIS THERAP FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Final approval of NDA #NDA #219491 for ZOLIFLODACIN. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for THALLOUS CHLORIDE TL 201 FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Labeling changes approved for CURIUM. Active ingredient: THALLOUS CHLORIDE TL-201. Decision date: 12/10/2025 Comment Full text
FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA regulatory update for ROLVEDON FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Administrative update #SUPPL-11 for SPECTRUM PHARMS. Status: Approval. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for MOMETASONE FUROATE FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for FOUGERA PHARMS. Active ingredient: MOMETASONE FUROATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for MEROPENEM FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for BROOKS STERISCIENCE. Active ingredient: MEROPENEM. Decision date: 12/11/2025 Comment Full text