FDA approves manufacturing change for BENAZEPRIL HYDROCHLORIDE FDA Approval Jan. 14, 2026, 23:09 UTC 17 0 comments Manufacturing process update for AUROBINDO PHARMA. Submission: SUPPL-28. Decision date: 01/13/2026 Comment Full text
FDA approves LAMOTRIGINE from TORRENT FDA Approval Jan. 14, 2026, 23:09 UTC 28 0 comments Final approval of ANDA #ANDA #217100 for LAMOTRIGINE. Decision date: 01/08/2026 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Jan. 13, 2026, 09:37 UTC 19 0 comments Labeling changes approved for VISTAPHARM LLC. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 01/06/2026 Comment Full text
FDA updates labeling for METHYLPHENIDATE HYDROCHLORIDE FDA Approval Jan. 13, 2026, 09:37 UTC 16 0 comments Labeling changes approved for ABHAI LLC. Active ingredient: METHYLPHENIDATE HYDROCHLORIDE. Decision date: 01/09/2026 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Jan. 13, 2026, 09:37 UTC 16 0 comments Labeling changes approved for NOVEL LABS INC. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 01/06/2026 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Jan. 13, 2026, 09:37 UTC 17 0 comments Labeling changes approved for HIKMA. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 01/06/2026 Comment Full text
FDA approves FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE from RESPIRENT PHARMS FDA Approval Jan. 13, 2026, 09:37 UTC 18 0 comments Final approval of ANDA #ANDA #214464 for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE. Decision date: 01/12/2026 Comment Full text
FDA approves SUCRALFATE from GLENMARK PHARMS LTD FDA Approval Jan. 13, 2026, 09:37 UTC 15 0 comments Final approval of ANDA #ANDA #212141 for SUCRALFATE. Decision date: 01/05/2026 Comment Full text
FDA approves EVEROLIMUS from BIOCON PHARMA FDA Approval Jan. 13, 2026, 05:11 UTC 15 0 comments Final approval of ANDA #ANDA #217216 for EVEROLIMUS. Decision date: 01/09/2026 Comment Full text
FDA approves SAPROPTERIN DIHYDROCHLORIDE from MICRO LABS FDA Approval Jan. 13, 2026, 05:11 UTC 14 0 comments Final approval of ANDA #ANDA #219511 for SAPROPTERIN DIHYDROCHLORIDE. Decision date: 01/08/2026 Comment Full text