Regulatory UpdatesAug 30, 2026•1 min read

FDA Discontinues FLUTEX Topical Ointment (ANDA087377)

By the PharmaCountry team

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.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ANDA #topical #ointment #triac #IVAX #FDA