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Details for New Drug Application (NDA): 077690

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NDA 077690 describes QUINAPRIL HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Sandoz, Teva, Prinston Inc, Aurobindo Pharma Ltd, Mylan, Apotex Inc, Actavis Labs Fl Inc, Invagen Pharms, Actavis Elizabeth, Lupin, Apotex Corp, and Aurobindo Pharma, and is included in eighteen NDAs. It is available from sixteen suppliers. Additional details are available on the QUINAPRIL HYDROCHLORIDE profile page.

The generic ingredient in QUINAPRIL HYDROCHLORIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.

Summary for NDA: 077690

Tradename:
QUINAPRIL HYDROCHLORIDE
Applicant:
Lupin
Ingredient:
quinapril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077690

Suppliers and Packaging for NDA: 077690

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE
quinapril hydrochloride
TABLET;ORAL 077690 ANDA Rebel Distributors Corp 21695-393 21695-393-30 30 TABLET in 1 BOTTLE (21695-393-30)
QUINAPRIL HYDROCHLORIDE
quinapril hydrochloride
TABLET;ORAL 077690 ANDA Rebel Distributors Corp 21695-394 21695-394-30 30 TABLET in 1 BOTTLE (21695-394-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jun 20, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jun 20, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jun 20, 2006TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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