Requests that the FDA to confirm that Diclofenac Sodium Plaster 1% is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-4911

Requests that the FDA to confirm that Diclofenac Sodium Plaster 1% is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 8, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Laboflex, Inc.	Mar 23, 2026	--

Keywords

CDER

Suitability Petition

Laboflex Inc

confirm that Diclofenac Sodium Plaster 1%

is suitable for submission

in an Abbreviated New Drug Application

CLOSED

Data from Regulations.gov