FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for AMNEAL PHARMS NY. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for REZDIFFRA FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for MADRIGAL. Active ingredient: RESMETIROM. Decision date: 12/19/2025 Comment Full text
FDA approves NUFYMCO from FORMYCON AG FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of BLA #BLA #761473 for RANIBIZUMAB-LEYK. Decision date: 12/18/2025 Comment Full text
FDA approves HALOPERIDOL from CREEKWOOD PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #218162 for HALOPERIDOL. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for FLONASE SENSIMIST ALLERGY RELIEF FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for HALEON US HOLDINGS. Active ingredient: FLUTICASONE FUROATE. Decision date: 12/19/2025 Comment Full text
FDA approves NITROGLYCERIN from SOLARIS PHARMA CORP FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of ANDA #ANDA #218756 for NITROGLYCERIN. Decision date: 12/18/2025 Comment Full text
FDA approves manufacturing change for NICARDIPINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Manufacturing process update for CHENGDU SHUODE. Submission: SUPPL-1. Decision date: 12/18/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for VARENICLINE TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for LUPIN LTD. Active ingredient: VARENICLINE TARTRATE. Decision date: 12/18/2025 Comment Full text