The FDA database entry for ANDA087377 lists the product FLUTEX as a topical ointment. The formulation contains 0.1% Triamcinolone Acetoinide and is identified with product number 001. It is not a reference drug and has a marketing status of Discontinued.
The sponsor for this application is IVAX PHARMS. Submission history shows an original (ORIG) submission (number 1) that received approval on November 1, 1988. A supplemental (SUPPL) labeling submission (number 2) was approved on October 27, 1992. No reference standard is indicated for the product.
規制動向2026年8月30日•1分で読めます
FDA Discontinues FLUTEX Topical Ointment (ANDA087377)
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FDA records indicate the FLUTEX topical ointment (0.1% Triamcinolone Acetoinide) by IVAX PHARMS is discontinued, with original ANDA approval in 1988 and a labeling supplement in 1992.
PharmaCountryチームがまとめました · 出典： FDA.gov
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