Requests that the FDA declare that an ANDA may be submitted for, Acetazolamide Tablets, USP 500 mg a strength that differs from the currently approved RLD, DIAMOX (Acetazolamide) tablets from TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC, which FDA approved in 125 mg and 250 mg strengths prior to Jan 1, 1982 under NDA #008943 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4761

Requests that the FDA declare that an ANDA may be submitted for, Acetazolamide Tablets, USP 500 mg a strength that differs from the currently approved RLD, DIAMOX (Acetazolamide) tablets from TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC, which FDA approved in 125 mg and 250 mg strengths prior to Jan 1, 1982 under NDA #008943

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMay 1, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Attachment 3	May 1, 2026	--

Keywords

CDER

Suitability Petition

Appco Pharma LLC

Requests that the FDA declare that an ANDA

may be submitted for, Acetazolamide Tablets,

USP 500 mg a strength that differs from the

currently approved RLD, DIAMOX (Acetazolamide)

tablets from TEVA BRANDED PHARMACEUTICAL

Data from Regulations.gov