Requests that the FDA determine whether TOLECTIN DS (Tolmetin Capsules 200 mg), approved under New Drug Application (“NDA”) number 018084, held by ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC, has been voluntarily withdrawn for reasons of safety or effectiveness. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-3575

Requests that the FDA determine whether TOLECTIN DS (Tolmetin Capsules 200 mg), approved under New Drug Application (“NDA”) number 018084, held by ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC, has been voluntarily withdrawn for reasons of safety or effectiveness.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensSep 11, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Letter from FDA CDER to Senores Pharmaceuticals, Inc.	Feb 19, 2026	--

Keywords

CDER

Citizen Petition

Senores Pharmaceuticals Inc

determine whether TOLECTIN

DS Tolmetin Capsules 200 mg approved under

New Drug Application number 018084 held by

ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

has been voluntarily

Data from Regulations.gov