FDA approves LATANOPROST from MANKIND PHARMA FDA Approval Dec. 19, 2025, 09:57 UTC 36 0 comments Final approval of ANDA #ANDA #220360 for LATANOPROST. Decision date: 12/17/2025 Comment Full text
FDA approves TRAVOPROST from ALEMBIC FDA Approval Dec. 19, 2025, 08:16 UTC 38 0 comments Final approval of ANDA #ANDA #214687 for TRAVOPROST. Decision date: 12/17/2025 Comment Full text
FDA regulatory update for ROLVEDON FDA Approval Dec. 18, 2025, 14:02 UTC 40 0 comments Administrative update #SUPPL-11 for SPECTRUM PHARMS. Status: Approval. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for VINCRISTINE SULFATE PFS FDA Approval Dec. 18, 2025, 09:45 UTC 35 0 comments Labeling changes approved for HOSPIRA. Active ingredient: VINCRISTINE SULFATE. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for CIPROFLOXACIN HYDROCHLORIDE FDA Approval Dec. 18, 2025, 09:45 UTC 44 0 comments Labeling changes approved for UNIQUE. Active ingredient: CIPROFLOXACIN HYDROCHLORIDE. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TIZANIDINE HYDROCHLORIDE FDA Approval Dec. 18, 2025, 09:45 UTC 31 0 comments Labeling changes approved for APOTEX INC. Active ingredient: TIZANIDINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA approves BORTEZOMIB from SHUANGCHENG FDA Approval Dec. 18, 2025, 09:45 UTC 35 0 comments Final approval of ANDA #ANDA #216528 for BORTEZOMIB. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TESTOSTERONE FDA Approval Dec. 18, 2025, 09:45 UTC 36 0 comments Labeling changes approved for ENCUBE. Active ingredient: TESTOSTERONE. Decision date: 12/17/2025 Comment Full text
FDA approves HYDROXYZINE HYDROCHLORIDE from NOVITIUM PHARMA FDA Approval Dec. 18, 2025, 05:15 UTC 39 0 comments Final approval of ANDA #ANDA #219648 for HYDROXYZINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA regulatory update for EXDENSUR FDA Approval Dec. 17, 2025, 20:01 UTC 51 0 comments Administrative update #SUPPL-1 for GLAXOSMITHKLINE LLC. Status: Approval. Decision date: 12/16/2025 Comment Full text