Requests that the FDA declare that the drug product, norethindrone acetate 1 mg / ethinyl estradiol 15 mcg capsules and ferrous fumarate 75 mg capsules, is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-7276

Requests that the FDA declare that the drug product, norethindrone acetate 1 mg / ethinyl estradiol 15 mcg capsules and ferrous fumarate 75 mg capsules, is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJun 30, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Withdrawal Request Letter from Neuvosyn Laboratories, LLC	Jul 27, 2026	--

Keywords

CDER

Suitability Petition

Neuvosyn Laboratories LLC

declare that the drug product norethindrone

acetate 1 mg / ethinyl estradiol 15 mcg

capsules and ferrous fumarate 75 mg capsules

is suitable for submission

in an Abbreviated New Drug Application

Data from Regulations.gov