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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077912

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NDA 077912 describes LISINOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Inc, Aurobindo, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from forty-two suppliers. Additional details are available on the LISINOPRIL AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in LISINOPRIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; lisinopril. There are thirty-one drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 077912
Tradename:LISINOPRIL AND HYDROCHLOROTHIAZIDE
Applicant:Lupin
Ingredient:hydrochlorothiazide; lisinopril
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077912
Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 077912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077912 ANDA Blenheim Pharmacal, Inc. 10544-236 E 10544-236-30
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077912 ANDA Blenheim Pharmacal, Inc. 10544-237 E 10544-237-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;10MG
Approval Date:Sep 27, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Sep 27, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;20MG
Approval Date:Sep 27, 2006TE:ABRLD:No

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