FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 10, 2025, 09:37 UTC 44 0 comments Labeling changes approved for HIBROW HLTHCARE. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA expands indications for RECARBRIO FDA Approval Dec. 10, 2025, 09:37 UTC 41 0 comments MSD MERCK CO receives approval for new indications. Submission: SUPPL-8. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for EPLERENONE FDA Approval Dec. 09, 2025, 09:42 UTC 45 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 41 0 comments Final approval of ANDA #ANDA #219096 for ACETAMINOPHEN. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 08, 2025, 09:39 UTC 42 0 comments Labeling changes approved for TORRENT PHARMS LTD. Active ingredient: OLANZAPINE. Decision date: 12/02/2025 Comment Full text
FDA approves MACITENTAN from MYLAN FDA Approval Dec. 08, 2025, 09:39 UTC 31 0 comments Final approval of ANDA #ANDA #211161 for MACITENTAN. Decision date: 12/03/2025 Comment Full text
FDA regulatory update for ONTRUZANT FDA Approval Dec. 08, 2025, 09:39 UTC 31 0 comments Administrative update #SUPPL-28 for SAMSUNG BIOEPIS CO LTD. Status: Approval. Decision date: 12/05/2025 Comment Full text
FDA approves MACITENTAN from SEASONS BIOTECH FDA Approval Dec. 05, 2025, 12:44 UTC 28 0 comments Final approval of ANDA #ANDA #211026 for MACITENTAN. Decision date: 12/03/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 05, 2025, 12:44 UTC 26 0 comments Labeling changes approved for TORRENT. Active ingredient: OLANZAPINE. Decision date: 12/03/2025 Comment Full text
FDA approves PROPOFOL from NANJING KING FRIEND FDA Approval Dec. 05, 2025, 12:44 UTC 42 0 comments Final approval of ANDA #ANDA #217945 for PROPOFOL. Decision date: 12/02/2025 Comment Full text