The U.S. Food and Drug Administration has granted approval for labeling of Mylan's Nisoldipine extended‑release tablets under ANDA 079051. The approval covers three oral tablet strengths—20 mg, 30 mg, and 40 mg—formulated as extended‑release products.
The original application (submission type ORIG) was filed and approved in July 2008, with an approval letter dated July 31, 2008. A supplemental submission (submission type SUPPL) received approval on August 11, 2022.
All three products are recorded with a marketing status of “Discontinued,” indicating they are no longer marketed despite the FDA approval.
The sponsor for the application is Mylan.
Regulatory UpdatesSep 9, 2026•3 min read
FDA Approves Mylan Nisoldipine Extended‑Release Tablets (ANDA 079051) – Discontinued Products
The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.
Compiled by the Pharmacountry team · Source: FDA.gov
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