Requests that the FDA declare that an ANDA may be submitted for Methylphenidate Hydrochloride Chewable Tablets, 20 mg, a strength that differs from the currently approved RLD, METHYLIN (Methylphenidate Hydrochloride) Chewable Tablets, 2.5 mg, 5 mg and 10 mg, NDA # 021475, held by SPECGX LLC. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5439

Requests that the FDA declare that an ANDA may be submitted for Methylphenidate Hydrochloride Chewable Tablets, 20 mg, a strength that differs from the currently approved RLD, METHYLIN (Methylphenidate Hydrochloride) Chewable Tablets, 2.5 mg, 5 mg and 10 mg, NDA # 021475, held by SPECGX LLC.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 17, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Rising Pharma Holdings, Inc.	Mar 23, 2026	--

Keywords

CDER

Suitability Petition

Rising Pharma Holdings Inc

declare that an ANDA may be submitted for

Methylphenidate Hydrochloride Chewable Tablets

20 mg

a strength that

differs from the currently approved RLD

Data from Regulations.gov