FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 15, 2025, 09:50 UTC 26 0 comments Labeling changes approved for ALKEM LABS LTD. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for CABERGOLINE FDA Approval Dec. 15, 2025, 09:50 UTC 33 0 comments Labeling changes approved for INGENUS PHARMS LLC. Active ingredient: CABERGOLINE. Decision date: 12/11/2025 Comment Full text
FDA approves OMEPRAZOLE AND SODIUM BICARBONATE from NOVITIUM PHARMA FDA Approval Dec. 15, 2025, 09:50 UTC 26 0 comments Final approval of ANDA #ANDA #219161 for OMEPRAZOLE; SODIUM BICARBONATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for AMANTADINE HYDROCHLORIDE FDA Approval Dec. 15, 2025, 09:50 UTC 25 0 comments Labeling changes approved for SHREE HARI INTL. Active ingredient: AMANTADINE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from SPECGX LLC FDA Approval Dec. 15, 2025, 09:50 UTC 25 0 comments Final approval of ANDA #ANDA #218473 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA approves DEFERIPRONE from SENORES PHARMS FDA Approval Dec. 12, 2025, 23:41 UTC 23 0 comments Final approval of ANDA #ANDA #220132 for . Decision date: 12/11/2025 Comment Full text
FDA approves DAYBUE STIX from ACADIA PHARMS INC FDA Approval Dec. 12, 2025, 23:41 UTC 26 0 comments Final approval of NDA #NDA #219884 for TROFINETIDE. Decision date: 12/11/2025 Comment Full text
FDA approves ORLADEYO from BIOCRYST PHARMACEUTICALS, INC FDA Approval Dec. 12, 2025, 23:41 UTC 44 0 comments Final approval of NDA #NDA #219776 for BEROTRALSTAT. Decision date: 12/11/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE from AUROBINDO PHARMA LIMITED FDA Approval Dec. 12, 2025, 18:18 UTC 40 0 comments Tentative approval of ANDA #ANDA #211489 for DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA grants tentative approval for MIRABEGRON from SUNSHINE LAKE PHARMA CO LTD FDA Approval Dec. 12, 2025, 18:18 UTC 33 0 comments Tentative approval of ANDA #ANDA #216757 for MIRABEGRON. Decision date: 12/10/2025 Comment Full text