FDA clears five ANDA supplements for Teva and Actavis Labs generics, mostly labeling updates

FDA approved a batch of supplemental applications across five ANDAs during the week, most tied to labeling changes.

• A REMS-related supplement for buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, sponsored by Teva Pharms USA, was approved under ANDA091149, supplement number 29, with a status date of 2026-08-14.¹
• A labeling supplement for metformin hydrochloride extended-release tablets, 500MG, sponsored by Actavis Labs FL Inc, was approved under ANDA076172, supplement number 30, with a status date of 2026-08-11.²
• A separate labeling supplement for metformin hydrochloride extended-release tablets, 750MG, also sponsored by Actavis Labs FL Inc, was approved under ANDA076869, supplement number 29, with a status date of 2026-08-11.³
• A labeling supplement for glipizide and metformin hydrochloride tablets, sponsored by Teva Pharms, was approved under ANDA077270, supplement number 16, with a status date of 2026-08-11.⁴
• A labeling supplement for vardenafil hydrochloride tablets, sponsored by Teva Pharms, was approved under ANDA091347, supplement number 7, with a status date of 2026-08-11.⁵