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FDA Approval

Chloroquine Phosphate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
AvKARE
DUNS: 796560394
Effective Date
November 15, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chloroquine(500 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chloroquine Phosphate

Product Details

NDC Product Code
42291-047
Application Number
ANDA040516
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 15, 2023
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
Code: 6E17K3343PClass: ACTIBQuantity: 500 mg in 1 1
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