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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Federal Trade Commission
Julphar
Accenture
Covington
Moodys
Baxter
Boehringer Ingelheim

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076113

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NDA 076113 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 thirty-four 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-two drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 076113
Tradename:LISINOPRIL AND HYDROCHLOROTHIAZIDE
Applicant:Mylan
Ingredient:hydrochlorothiazide; lisinopril
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076113
Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 076113
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 076113 ANDA Mylan Pharmaceuticals Inc. 0378-1012 N 0378-1012-01
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 076113 ANDA Mylan Pharmaceuticals Inc. 0378-2012 N 0378-2012-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;10MG
Approval Date:Jul 1, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Jul 1, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;20MG
Approval Date:Jul 1, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Merck
Argus Health
Citi
Dow
Covington
AstraZeneca
Cerilliant
Daiichi Sankyo

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