Requests that the FDA declare that the drug product, Bupropion Hydrochloride Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-0748

Requests that the FDA declare that the drug product, Bupropion Hydrochloride Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Key Dates

Comment Period OpensJan 26, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Feb 25, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals Inc

declare that the drug product

Bupropion Hydrochloride Tablets 150 mg

is suitable for submission in an

Abbreviated New Drug Application

OPEN

Data from Regulations.gov