FDA approves ACETAMINOPHEN AND IBUPROFEN from TARO FDA Approval Jan. 06, 2026, 15:52 UTC 60 0 comments Final approval of ANDA #ANDA #219053 for ACETAMINOPHEN; IBUPROFEN. Decision date: 01/02/2026 Comment Full text
FDA updates labeling for CARBAMAZEPINE FDA Approval Jan. 06, 2026, 09:50 UTC 53 0 comments Labeling changes approved for AMNEAL PHARMS. Active ingredient: CARBAMAZEPINE. Decision date: 01/05/2026 Comment Full text
FDA approves EXTENDED PHENYTOIN SODIUM from MANKIND PHARMA FDA Approval Jan. 06, 2026, 09:50 UTC 53 0 comments Final approval of ANDA #ANDA #219773 for PHENYTOIN SODIUM. Decision date: 01/02/2026 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from ALKEM LABS LTD FDA Approval Jan. 05, 2026, 09:58 UTC 65 0 comments Tentative approval of ANDA #ANDA #211545 for DAPAGLIFLOZIN. Decision date: 01/02/2026 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ORLADEYO FDA Approval Dec. 31, 2025, 13:45 UTC 61 0 comments Labeling changes approved for BIOCRYST. Active ingredient: BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA approves POTASSIUM CHLORIDE from QUAGEN FDA Approval Dec. 31, 2025, 13:45 UTC 50 0 comments Final approval of ANDA #ANDA #215716 for POTASSIUM CHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves METHYLENE BLUE from CHENGDU SHUODE FDA Approval Dec. 31, 2025, 13:45 UTC 47 0 comments Final approval of ANDA #ANDA #219550 for METHYLENE BLUE. Decision date: 12/23/2025 Comment Full text
FDA approves PSEUDOEPHEDRINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Final approval of ANDA #ANDA #218854 for PSEUDOEPHEDRINE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Labeling changes approved for CHARTWELL. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text