Request that the FDA determine whether Dilaudid-HP (hydromorphone hydrochloride) 10 mg/mL, (NDA 019034) held by Fresenius Kabi USA LLC has been voluntarily withdrawn or withheld from sale for reasons of safety or efficacy | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2718

Request that the FDA determine whether Dilaudid-HP (hydromorphone hydrochloride) 10 mg/mL, (NDA 019034) held by Fresenius Kabi USA LLC has been voluntarily withdrawn or withheld from sale for reasons of safety or efficacy

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMar 17, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Attachment 1_Orange Book_ Approved Drug Products with Therapeutic Equivalence Evaluations	Mar 17, 2026	--

Keywords

CDER

Citizen Petition

Apotex Inc.

determine whether Dilaudid-HP

(hydromorphone hydrochloride) 10 mg/mL,

(NDA 019034) held by Fresenius Kabi USA LLC

has been voluntarily withdrawn or withheld from

sale for reasons of safety or efficacy

Data from Regulations.gov