Senores Pharms submitted ANDA090353 to the FDA for generic Topiramate tablets. The application covers oral tablet products with strengths of 25 mg, 50 mg, 100 mg, and 200 mg.
The FDA records show two submissions: an original (ORIG) submission filed on 2010‑09‑01 that received approval, and a supplemental (SUPPL) labeling submission filed on 2017‑01‑24, also approved.
Four Topiramate tablet products are listed under this ANDA, each with a distinct product number (001‑004) and dosage strength. All four are marked as "Discontinued" in marketing status, indicating they are no longer marketed despite FDA approval.
規制動向2026年9月16日•3分で読めます
FDA Approves ANDA090353 for Senores Pharms Topiramate Tablets (Discontinued)
Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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