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Regulatory UpdatesSep 25, 2026•1 min read

FDA ANDA088048 Approval for Fluocinolone Acetonide Topical Solution (Discontinued)

By the PharmaCountry team

The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.

The U.S. Food and Drug Administration (FDA) has an entry for ANDA088048 concerning a topical solution product containing fluocinolone acetonide 0.01%. The product, marketed under the brand name Fluocinolone Acetonide, was submitted by the sponsor Allied. FDA records indicate the product’s marketing status is discontinued and it is not a reference drug. No reference standard is listed, and the product is classified as a solution for topical administration.

Compiled by the PharmaCountry team · Source: FDA.gov

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