FDA approves SAPROPTERIN DIHYDROCHLORIDE from MICRO LABS FDA Approval Jan. 13, 2026, 05:11 UTC 83 0 comments Final approval of ANDA #ANDA #219511 for SAPROPTERIN DIHYDROCHLORIDE. Decision date: 01/08/2026 Comment Full text
FDA approves ZYCUBO from SENTYNL THERAPS INC FDA Approval Jan. 12, 2026, 21:49 UTC 56 0 comments Final approval of NDA #NDA #211241 for COPPER HISTIDINATE. Decision date: 01/12/2026 Comment Full text
FDA approves manufacturing change for MAGNESIUM SULFATE IN PLASTIC CONTAINER FDA Approval Jan. 12, 2026, 09:57 UTC 53 0 comments Manufacturing process update for BAXTER HLTHCARE CORP. Submission: SUPPL-11. Decision date: 01/08/2026 Comment Full text
FDA grants tentative approval for AMPHETAMINE from GRANULES PHARMACEUTICALS INC FDA Approval Jan. 09, 2026, 17:15 UTC 52 0 comments Tentative approval of ANDA #ANDA #220284 for AMPHETAMINE. Decision date: 01/07/2026 Comment Full text
FDA grants tentative approval for RIFAXIMIN from MYLAN PHARMACEUTICALS INC FDA Approval Jan. 09, 2026, 17:15 UTC 57 0 comments Tentative approval of ANDA #ANDA #219687 for RIFAXIMIN. Decision date: 01/07/2026 Comment Full text
FDA grants tentative approval for SELENIOUS ACID from BPI LABS LLC FDA Approval Jan. 09, 2026, 16:40 UTC 53 0 comments Tentative approval of ANDA #ANDA #220051 for SELENIOUS ACID. Decision date: 01/07/2026 Comment Full text
FDA grants tentative approval for GLYCEROL PHENYLBUTYRATE from AUROBINDO PHARMA LIMITED FDA Approval Jan. 09, 2026, 16:24 UTC 62 0 comments Tentative approval of ANDA #ANDA #220313 for GLYCEROL PHENYLBUTYRATE. Decision date: 01/07/2026 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from SCIEGEN PHARMACEUTICALS INC FDA Approval Jan. 09, 2026, 16:24 UTC 54 0 comments Tentative approval of ANDA #ANDA #219408 for DAPAGLIFLOZIN. Decision date: 01/08/2026 Comment Full text
FDA grants tentative approval for NINTEDANIB from HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD FDA Approval Jan. 09, 2026, 15:47 UTC 61 0 comments Tentative approval of ANDA #ANDA #218472 for NINTEDANIB. Decision date: 01/07/2026 Comment Full text
FDA updates labeling for PROTRIPTYLINE HYDROCHLORIDE FDA Approval Jan. 09, 2026, 09:53 UTC 64 0 comments Labeling changes approved for EPIC PHARMA LLC. Active ingredient: PROTRIPTYLINE HYDROCHLORIDE. Decision date: 01/07/2026 Comment Full text