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Generated: April 23, 2017

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Details for New Drug Application (NDA): 090612

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NDA 090612 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 seven suppliers. Additional details are available on the CHLOROQUINE PHOSPHATE profile page.

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

Summary for NDA: 090612

Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 090612

Suppliers and Packaging for NDA: 090612

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
chloroquine phosphate
TABLET;ORAL 090612 ANDA Rising Pharmaceuticals, Inc. 64980-178 64980-178-01 100 TABLET in 1 BOTTLE, PLASTIC (64980-178-01)
chloroquine phosphate
TABLET;ORAL 090612 ANDA Rising Pharmaceuticals, Inc. 64980-178 64980-178-02 25 TABLET in 1 BOTTLE, PLASTIC (64980-178-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Jan 21, 2011TE:AARLD:No

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