Regulatory UpdatesSep 22, 2026•1 min read

FDA Approves Buprenorphine ANDA078633 Sublingual Tablets

By the PharmaCountry team

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.

The U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application (ANDA) identified as ANDA078633 for buprenorphine tablets. The approved products are sublingual tablets manufactured by Hikma Pharmaceuticals USA Inc. Two dosage strengths are listed: 2 mg and 8 mg buprenorphine hydrochloride base equivalents. Both products are classified as prescription‑only human prescription drugs and carry National Drug Code (NDC) identifiers 0054-0176-13 and 0054-0177-13. The approval package includes multiple labeling submissions (submission numbers 12, 18, 20, 24, 26, 28) dated between 2019 and 2022, as well as Risk Evaluation and Mitigation Strategy (REMS) submissions (numbers 6, 16, 30) with dates ranging from 2015 to 2024. No reference drug status was indicated for either product.

Compiled by the PharmaCountry team · Source: FDA.gov