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Chloroquine Phosphate

Chloroquine Phosphate Tablets, USP (500 mg) Rx only

Approved
Approval ID

0a342f72-45f9-3e12-e063-6394a90ae33e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2023

Manufacturers
FDA

AvKARE

DUNS: 796560394

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 Code42291-047
Application NumberANDA040516
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLOROQUINE PHOSPHATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification

INGREDIENTS (7)

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

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Chloroquine Phosphate - FDA Drug Approval Details