FDA grants tentative approval for RIFAXIMIN from CIPLA LTD FDA Approval Dec. 12, 2025, 18:18 UTC 32 0 comments Tentative approval of ANDA #ANDA #219570 for RIFAXIMIN. Decision date: 12/08/2025 Comment Full text
FDA grants tentative approval for CARBIDOPA AND LEVODOPA from BIOCON PHARMA LIMITED FDA Approval Dec. 12, 2025, 18:18 UTC 38 0 comments Tentative approval of ANDA #ANDA #220119 for CARBIDOPA,LEVODOPA. Decision date: 12/04/2025 Comment Full text
FDA grants tentative approval for CLADRIBINE from HOPEWELL PHARMA VENTURES, INC. FDA Approval Dec. 12, 2025, 18:18 UTC 30 0 comments Tentative approval of ANDA #ANDA #215547 for CLADRIBINE. Decision date: 12/04/2025 Comment Full text
FDA approves EPINEPHRINE from AMNEAL FDA Approval Dec. 12, 2025, 09:56 UTC 43 0 comments Final approval of ANDA #ANDA #218208 for EPINEPHRINE. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 12, 2025, 09:56 UTC 27 0 comments Labeling changes approved for HIKMA. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 12, 2025, 09:56 UTC 39 0 comments Labeling changes approved for ANI PHARMS. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 12, 2025, 09:56 UTC 37 0 comments Labeling changes approved for PHARM ASSOC. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA approves ISOPROTERENOL HYDROCHLORIDE from DEVA HOLDING AS FDA Approval Dec. 12, 2025, 05:09 UTC 31 0 comments Final approval of ANDA #ANDA #213305 for ISOPROTERENOL HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA approves LOTEPREDNOL ETABONATE AND TOBRAMYCIN from ALEMBIC FDA Approval Dec. 12, 2025, 05:09 UTC 33 0 comments Final approval of ANDA #ANDA #217597 for LOTEPREDNOL ETABONATE; TOBRAMYCIN. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for REZZAYO FDA Approval Dec. 11, 2025, 09:44 UTC 35 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text