FDA approves PROPOFOL from NANJING KING FRIEND FDA Approval Dec. 05, 2025, 12:44 UTC 8 0 comments Final approval of ANDA #ANDA #217945 for PROPOFOL. Decision date: 12/02/2025 Comment Full text
FDA approves MACITENTAN from SEASONS BIOTECH FDA Approval Dec. 05, 2025, 12:44 UTC 3 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 2 0 comments Labeling changes approved for TORRENT. Active ingredient: OLANZAPINE. Decision date: 12/03/2025 Comment Full text
FDA approves manufacturing change for CEFAZOLIN SODIUM FDA Approval Dec. 04, 2025, 19:12 UTC 8 0 comments Manufacturing process update for HIKMA FARMACEUTICA. Submission: SUPPL-34. Decision date: 12/01/2025 Comment Full text
SANDOZ FDA Approval Dec. 04, 2025, 09:53 UTC 6 0 comments FDA approve METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE Comment Full text
AMNEAL IRELAND LTD FDA Approval Dec. 03, 2025, 09:44 UTC 10 0 comments FDA approve ALBUTEROL SULFATE Comment Full text
ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. FDA Approval Nov. 28, 2025, 14:17 UTC 11 0 comments FDA approve METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE Comment Full text
CHANGZHOU PHARMACEUTICAL FACTORY FDA Approval Nov. 28, 2025, 14:17 UTC 4 0 comments FDA approve RIMEGEPANT SULFATE Comment Full text
ABBVIE FDA Approval Nov. 28, 2025, 13:43 UTC 3 0 comments FDA approve PREDNISOLONE ACETATE Comment Full text