FDA approves manufacturing change for METOLAZONE FDA Approval Jan. 09, 2026, 09:53 UTC 9 0 comments Manufacturing process update for INNOGENIX. Submission: SUPPL-3. Decision date: 01/07/2026 Comment Full text
FDA approves ENOXAPARIN SODIUM (PRESERVATIVE FREE) from HEBEI CHANGSHAN FDA Approval Jan. 09, 2026, 09:53 UTC 10 0 comments Final approval of ANDA #ANDA #218775 for ENOXAPARIN SODIUM. Decision date: 01/07/2026 Comment Full text
FDA updates labeling for ACETAZOLAMIDE FDA Approval Jan. 09, 2026, 09:53 UTC 10 0 comments Labeling changes approved for AUROBINDO PHARMA LTD. Active ingredient: ACETAZOLAMIDE. Decision date: 01/08/2026 Comment Full text
FDA updates labeling for NORGESTIMATE AND ETHINYL ESTRADIOL FDA Approval Jan. 09, 2026, 09:53 UTC 2 0 comments Labeling changes approved for MYLAN. Active ingredient: ETHINYL ESTRADIOL; NORGESTIMATE. Decision date: 01/07/2026 Comment Full text
FDA regulatory update for YESINTEK FDA Approval Jan. 08, 2026, 17:39 UTC 12 0 comments Administrative update #SUPPL-1 for BIOCON BIOLOGICS INC. Status: Approval. Decision date: 01/07/2026 Comment Full text
FDA approves BORTEZOMIB from GLAND FDA Approval Jan. 08, 2026, 09:54 UTC 2 0 comments Final approval of ANDA #ANDA #219167 for BORTEZOMIB. Decision date: 01/06/2026 Comment Full text
FDA approves OLOPATADINE HYDROCHLORIDE from GLAND FDA Approval Jan. 08, 2026, 09:54 UTC 2 0 comments Final approval of ANDA #ANDA #213514 for OLOPATADINE HYDROCHLORIDE. Decision date: 01/06/2026 Comment Full text
FDA approves ROCURONIUM BROMIDE from KNACK FDA Approval Jan. 08, 2026, 09:54 UTC 2 0 comments Final approval of ANDA #ANDA #213476 for ROCURONIUM BROMIDE. Decision date: 01/06/2026 Comment Full text
FDA approves CIPROFLOXACIN AND DEXAMETHASONE from UPSHER SMITH LABS FDA Approval Jan. 08, 2026, 05:13 UTC 2 0 comments Final approval of ANDA #ANDA #216487 for CIPROFLOXACIN; DEXAMETHASONE. Decision date: 01/06/2026 Comment Full text
FDA updates labeling for MECLIZINE HYDROCHLORIDE FDA Approval Jan. 07, 2026, 09:48 UTC 6 0 comments Labeling changes approved for RISING. Active ingredient: MECLIZINE HYDROCHLORIDE. Decision date: 01/06/2026 Comment Full text