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.