Requests that FDA declare that Cyclobenzaprine HCl Sublingual Tablets, 5.6 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7610

Requests that FDA declare that Cyclobenzaprine HCl Sublingual Tablets, 5.6 mg, is suitable for submission as an ANDA

Documents

Comments

Description

Open

Key Dates

Comment Period OpensJul 8, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jul 29, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Cyclobenzaprine HCl Sublingual Tablets, 5.6 mg,

is suitable for submission as an ANDA

the Reference Listed Drug (RLD) upon which

this petition is based is

Data from Regulations.gov