Regulatory UpdatesSep 5, 2026•1 min read

FDA Approves ANDA 076802 for Glimepiride Tablets (Discontinued)

By the PharmaCountry team

FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.

The FDA’s Center for Drug Evaluation and Research (CDER) has granted approval for ANDA 076802, covering generic oral tablets of glimepiride. The ANDA includes three tablet strengths – 1 mg (product 001), 2 mg (product 002) and 4 mg (product 003). All three are listed as discontinued in the FDA database. The original application (submission 1) was approved on 6 Oct 2005, with supporting review and approval letters available. Since then, the agency has issued a series of labeling supplements (submissions 6, 11, 12, 13, 14, 15, 16, 17, 20) that were all approved, the most recent on 31 May 2019. No reference drug or reference standard was identified for these products.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #GLIMEPIRIDE #tablet #regulatory #labeling