Request that the FDA declare that the drug product, Atomoxetine Hydrochloride, Solution, eq 5 mg base/mL, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2639

Request that the FDA declare that the drug product, Atomoxetine Hydrochloride, Solution, eq 5 mg base/mL, is suitable for submission as an ANDA

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMar 13, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Mar 26, 2026	--

Keywords

CDER

Suitability Petition

declare that the drug product

Atomoxetine Hydrochloride

Solution, eq 5 mg base/mL,

is suitable for submission as an ANDA

Oral

Reference Listed Drug (RLD)

Data from Regulations.gov