Request that the FDA determine and declare that Tizanidine Tablets, 3 mg and 6 mg, are suitable for submission in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

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FDA

FDA-2025-P-5492

Request that the FDA determine and declare that Tizanidine Tablets, 3 mg and 6 mg, are suitable for submission in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 20, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Mar 30, 2026	--

Keywords

CDER

Suitability Petition

Pharmobedient Consulting, LLC

determine and declare that Tizanidine Tablets

3 mg and 6 mg, are suitable for submission

in an Abbreviated New Drug Application (ANDA)

Reference Listed Drug (RLD)

Zanaflex (Tizanidine) Tablets

Data from Regulations.gov