PLAQUENIL (HYDROXYCHLOROQUINE SULFATE)
Summary
FDA approved PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) by ADVANZ PHARMA. NDA (New Drug) approval (Labeling) on 2023-12-12. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA009768-54
Action Date
2023-12-12
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
PLAQUENIL (generic: HYDROXYCHLOROQUINE SULFATE), TABLET, ORAL. Application: NDA009768
Company
Context & Analysis
ADVANZ PHARMA has 2 FDA actions in our database.
Frequently Asked Questions
How often does ADVANZ PHARMA have FDA actions?
ADVANZ PHARMA has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA009768-54" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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