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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078450

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NDA 078450 describes QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Sun Pharm Inds Ltd, Apotex Corp, Aurobindo Pharma, Invagen Pharms, and Mylan, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.

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

Summary for NDA: 078450

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078450

Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 078450

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL 078450 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-998 35356-998-30 30 TABLET, FILM COATED in 1 BOTTLE (35356-998-30)
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL 078450 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-998 35356-998-60 60 TABLET, FILM COATED in 1 BOTTLE (35356-998-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 10MG BASE
Approval Date:Aug 24, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 20MG BASE
Approval Date:Aug 24, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;EQ 20MG BASE
Approval Date:Aug 24, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Dow
Medtronic
Teva
Accenture
Covington
Merck
US Department of Justice
Farmers Insurance
Colorcon
Federal Trade Commission

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