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.
규제 업데이트2026년 8월 30일•1분 읽기
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 팀이 정리했습니다 · 출처: FDA.gov
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