FDA approves LINEZOLID from CAPLIN FDA Approval Dec. 10, 2025, 09:37 UTC 0 0 comments Final approval of ANDA #ANDA #219558 for LINEZOLID. Decision date: 12/08/2025 Comment Full text
FDA expands indications for RECARBRIO FDA Approval Dec. 10, 2025, 09:37 UTC 0 0 comments MSD MERCK CO receives approval for new indications. Submission: SUPPL-8. Decision date: 12/09/2025 Comment Full text
FDA regulatory update for RYSTIGGO FDA Approval Dec. 10, 2025, 09:37 UTC 0 0 comments Administrative update #SUPPL-7 for UCB INC. Status: Approval. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 10, 2025, 09:37 UTC 0 0 comments Labeling changes approved for HIBROW HLTHCARE. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA approves ESTRADIOL from TEVA PHARMS USA INC FDA Approval Dec. 10, 2025, 09:37 UTC 0 0 comments Final approval of ANDA #ANDA #214137 for ESTRADIOL. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for EPLERENONE FDA Approval Dec. 09, 2025, 09:42 UTC 7 0 comments Labeling changes approved for RISING. Active ingredient: EPLERENONE. Decision date: 12/04/2025 Comment Full text
FDA approves ACETAMINOPHEN from CAPLIN FDA Approval Dec. 09, 2025, 05:09 UTC 5 0 comments Final approval of ANDA #ANDA #219096 for ACETAMINOPHEN. Decision date: 12/05/2025 Comment Full text
FDA approves MACITENTAN from MYLAN FDA Approval Dec. 08, 2025, 09:39 UTC 2 0 comments Final approval of ANDA #ANDA #211161 for MACITENTAN. Decision date: 12/03/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 08, 2025, 09:39 UTC 5 0 comments Labeling changes approved for TORRENT PHARMS LTD. Active ingredient: OLANZAPINE. Decision date: 12/02/2025 Comment Full text
FDA regulatory update for ONTRUZANT FDA Approval Dec. 08, 2025, 09:39 UTC 3 0 comments Administrative update #SUPPL-28 for SAMSUNG BIOEPIS CO LTD. Status: Approval. Decision date: 12/05/2025 Comment Full text