Regulatory UpdatesSep 28, 2026•1 min read

FDA Discontinues Hydrocortisone 0.5% Ointment (ANDA084969)

By the PharmaCountry team

The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.

The U.S. Food and Drug Administration (FDA) has recorded a regulatory status change for a topical product containing hydrocortisone. The product, identified as HYDROCORTISONE 0.5% OINTMENT (product number 003), is manufactured by Perrigo New York. According to the FDA’s database, the product is classified as a non‑reference drug and is now marked as "Discontinued" under the Abbreviated New Drug Application (ANDA) number ANDA084969. No reference standard is associated with this submission. Key details: - Route: Topical - Dosage form: Ointment - Active ingredient: Hydrocortisone 0.5% - Sponsor: Perrigo New York - Marketing status: Discontinued - Application number: ANDA084969

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#hydrocortisone #Topical Ointment #ANDA #discontinued #Perrigo #FDA