Requests that the FDA declare that Pimavanserin Tablets, 34 mg is suitable for submission as an ANDA. | Federal Regulations · Congress.wiki

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FDA

FDA-2024-P-0435

Requests that the FDA declare that Pimavanserin Tablets, 34 mg is suitable for submission as an ANDA.

Documents

Comments

Description

CLOSED

Comment Period OpensJan 23, 2024

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Zydus Pharmaceuticals (USA) Inc.	May 20, 2024	--

CDER

Suitability Petition

Requests that the FDA declare that

Pimavanserin Tablets, 34 mg is

suitable for submission as an ANDA.

CLOSED