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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

Effective Date
December 30, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chloroquine(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Amneal Pharmaceuticals Private Limited

Amneal Pharmaceuticals of New York LLC

915076126

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
0115-7010
Application Number
ANDA040516
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 30, 2023
Code: 6E17K3343PClass: ACTIBQuantity: 500 mg in 1 1
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EAClass: IACT
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
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