Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Buprenorphine ANDA078633 Sublingual Tablets
FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)
FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA210272 for Buprenorphine Transdermal Patch
The FDA has approved application ANDA210272 for a buprenorphine transdermal patch, covering five dosage strengths and requiring a REMS program.