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Chloroquine Phosphate

Chloroquine Phosphate Tablets, USP (500 mg) Rx only

Approved
Approval ID

eb02c52d-907c-43fb-aa8f-2f378a9087e7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2023

Manufacturers
FDA

Amneal Pharmaceuticals of New York LLC

DUNS: 123797875

Products 1

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

CHLOROQUINE PHOSPHATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-7010
Application NumberANDA040516
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLOROQUINE PHOSPHATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (7)

CHLOROQUINE PHOSPHATEActive
Quantity: 500 mg in 1 1
Code: 6E17K3343P
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT

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Chloroquine Phosphate - FDA Drug Approval Details