FDA approves VYBRIQUE from IBSA FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of NDA #NDA #210858 for SILDENAFIL CITRATE. Decision date: 12/16/2025 Comment Full text
FDA expands indications for ACCRUFER FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments SHIELD TX receives approval for new indications. Submission: SUPPL-19. Decision date: 12/19/2025 Comment Full text
FDA approves NITROGLYCERIN from SOLARIS PHARMA CORP FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Final approval of ANDA #ANDA #218756 for NITROGLYCERIN. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; IBUPROFEN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for WAINUA (AUTOINJECTOR) FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for ASTRAZENECA AB. Active ingredient: EPLONTERSEN SODIUM. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for AMNEAL PHARMS. Active ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves LATANOPROST from MANKIND PHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Final approval of ANDA #ANDA #220360 for LATANOPROST. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TIZANIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for APOTEX INC. Active ingredient: TIZANIDINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA approves TRAVOPROST from ALEMBIC FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #214687 for TRAVOPROST. Decision date: 12/17/2025 Comment Full text
FDA approves HALOPERIDOL from CREEKWOOD PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Final approval of ANDA #ANDA #218162 for HALOPERIDOL. Decision date: 12/18/2025 Comment Full text