FDA Discontinues FLUTEX Topical Ointment (ANDA087377)

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.