Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-7054

Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 15, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Unichem Pharmaceuticals (USA), Inc.	May 7, 2026	--

Keywords

CDER

Citizen Petition

Unichem Pharmaceuticals (USA), Inc.

determine whether the Reference Listed Drug

(RLD)

MICARDIS (Telmisartan Tablets, 20 mg and 80 mg)

under New Drug Application (NDA) N020850

held by Boehringer Ingelheim, was voluntarily

Data from Regulations.gov