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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Federal Trade Commission
Harvard Business School
Queensland Health
Fish and Richardson
Daiichi Sankyo

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083082

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NDA 083082 describes CHLOROQUINE PHOSPHATE, which is a drug marketed by Hikma Pharms, Impax Labs, Ipca Labs Ltd, Md Pharm, Natco Pharma Ltd, Purepac Pharm, Teva, and Watson Labs, and is included in twelve NDAs. It is available from five suppliers. Additional details are available on the CHLOROQUINE PHOSPHATE profile page.

The generic ingredient in CHLOROQUINE PHOSPHATE is chloroquine phosphate. There are twenty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chloroquine phosphate profile page.
Summary for 083082
Applicant:Hikma Pharms
Ingredient:chloroquine phosphate
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 083082
Suppliers and Packaging for NDA: 083082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 083082 ANDA West-ward Pharmaceutical Corp 0143-1195 N 0143-1195-01
CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 083082 ANDA West-ward Pharmaceutical Corp 0143-1195 N 0143-1195-05

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 17, 1999TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Daiichi Sankyo

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