Declare that Hydroxychloroquine Sulfate Tablets 100, 300, and 400 mg, are Suitable for Submission in an Abbreviated New Drug Application (ANDA); CLOSED | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2013-P-0170

Declare that Hydroxychloroquine Sulfate Tablets 100, 300, and 400 mg, are Suitable for Submission in an Abbreviated New Drug Application (ANDA); CLOSED

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensMar 1, 2013

Documents

Type	Title	Posted	Comments	Status
Other	Updated Response Letter from FDA CDER to Clinipace Worldwide	Jul 21, 2026	--

Keywords

cder

2013-1032

hydroxychloroquine

sulfate

tablet

NDA 09-768

Plaquenil

400 mg

ANDA

Data from Regulations.gov