Actualités réglementaires30 août 2026•1 min de lecture

FDA Discontinues FLUTEX Topical Ointment (ANDA087377)

Par l'équipe PharmaCountry

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.

Compilé par l'équipe PharmaCountry · Source : FDA.gov

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