The U.S. Food and Drug Administration (FDA) granted approval for application ANDA077831 submitted by Chartwell Rx. The approval covers two oral tablet products containing the active ingredient CILOSTAZOL: a 50 mg tablet (product number 002) and a 100 mg tablet (product number 001). Both products are classified as prescription drugs and are not designated as reference drugs or reference standards.
The original submission (type ORIG, submission number 1) received approval on September 24, 2012. A supplemental labeling submission (type SUPPL, submission number 1) was later approved on March 29, 2016, updating the product labeling information.
These approvals allow Chartwell Rx to market the CILOSTAZOL tablets in the United States under the specified strengths and dosage form.
規制動向2026年8月30日•1分で読めます
FDA Approves CILOSTAZOL Tablets (ANDA077831)
FDA has approved Chartwell Rx's ANDA077831 for oral CILOSTAZOL tablets in 50 mg and 100 mg strengths, with labeling updates approved in 2016.
PharmaCountryチームがまとめました · 出典： FDA.gov
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