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Details for New Drug Application (NDA): 080880

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NDA 080880 describes CHLOROQUINE PHOSPHATE, which is a drug marketed by Teva, Ipca Labs Ltd, Natco Pharma Ltd, Impax Labs, Md Pharm, Watson Labs, Hikma Pharms Llc, and Purepac Pharm, and is included in twelve NDAs. It is available from eight suppliers. Additional details are available on the CHLOROQUINE PHOSPHATE profile page.

The generic ingredient in CHLOROQUINE PHOSPHATE is chloroquine phosphate. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the chloroquine phosphate profile page.

Summary for NDA: 080880

Impax Labs
chloroquine phosphate
Therapeutic Class:Antiparasitics

Pharmacology for NDA: 080880

Suppliers and Packaging for NDA: 080880

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
chloroquine phosphate
TABLET;ORAL 080880 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-2790 0115-2790-02 500 TABLET in 1 BOTTLE (0115-2790-02)
chloroquine phosphate
TABLET;ORAL 080880 ANDA Global Pharmaceuticals, Division of Impax Laboratories, Inc. 0115-2790 0115-2790-06 50 TABLET in 1 BOTTLE (0115-2790-06)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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