FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)

The FDA database entry (ANDA090360) lists two sublingual buprenorphine hydrochloride tablet products that are currently marked as discontinued. Product 001 is equivalent to 2 mg buprenorphine base, and product 002 is equivalent to 8 mg base. Since the original application, the agency has recorded a series of supplemental (SUPPL) and original (ORIG) submissions. All listed submissions show an "AP" (approved) status. The submissions include multiple labeling updates (submission numbers 21, 13, 11, 28, 26, 18) spanning dates from 2016 to 2023, and several Risk Evaluation and Mitigation Strategy (REMS) submissions (numbers 7, 32, 24, 16) with dates ranging from 2015 to 2026. The original submission (number 1) was approved on 7 May 2010 and includes a REMS document. No active marketing status is indicated for these products, and the FDA records do not provide further clinical or commercial details. For complete documentation, refer to the FDA’s public database.