FDA approves MACITENTAN from SEASONS BIOTECH FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Final approval of ANDA #ANDA #211026 for MACITENTAN. Decision date: 12/03/2025 Comment Full text
FDA updates labeling for RIFADIN FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for SANOFI AVENTIS US. Active ingredient: RIFAMPIN. Decision date: 12/05/2025 Comment Full text
FDA grants tentative approval for CARBIDOPA AND LEVODOPA from BIOCON PHARMA LIMITED FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Tentative approval of ANDA #ANDA #220119 for CARBIDOPA,LEVODOPA. Decision date: 12/04/2025 Comment Full text
FDA regulatory update for TEVIMBRA FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Administrative update #SUPPL-15 for BEIGENE. Status: Approval. Decision date: 12/02/2025 Comment Full text
FDA expands indications for JAYPIRCA FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments LOXO ONCOL receives approval for new indications. Submission: SUPPL-5. Decision date: 12/02/2025 Comment Full text
FDA approves PROPOFOL from NANJING KING FRIEND FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Final approval of ANDA #ANDA #217945 for PROPOFOL. Decision date: 12/02/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for ELITE LABS INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/02/2025 Comment Full text
FDA approves LEVETIRACETAM from KNACK FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Final approval of ANDA #ANDA #215465 for LEVETIRACETAM. Decision date: 12/02/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Labeling changes approved for TORRENT PHARMS LTD. Active ingredient: OLANZAPINE. Decision date: 12/02/2025 Comment Full text
FDA approves SITAGLIPTIN AND METFORMIN HYDROCHLORIDE from SANDOZ FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Final approval of ANDA #ANDA #202388 for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE. Decision date: 12/02/2025 Comment Full text