Request that the FDA determine whether PROMETRIUM (progesterone) Capsules, 300 mg, approved under New Drug Application (NDA) number 019781, held by Acertis Pharmaceuticals LLC, has been voluntarily withdrawn for reasons of safety or effectiveness. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4018

Request that the FDA determine whether PROMETRIUM (progesterone) Capsules, 300 mg, approved under New Drug Application (NDA) number 019781, held by Acertis Pharmaceuticals LLC, has been voluntarily withdrawn for reasons of safety or effectiveness.

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensApr 13, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgment Letter from FDA DMB to Hyman, Phelps & McNamara, P.C.	Apr 13, 2026	--

Keywords

CDER

Citizen Petition

Hyman, Phelps & McNamara, P.C.

determine whether PROMETRIUM

(progesterone) Capsules, 300 mg,

approved under New Drug Application

(NDA) number 019781,

held by Acertis Pharmaceuticals LLC,

Data from Regulations.gov