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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075776

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NDA 075776 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 075776

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

Pharmacology for NDA: 075776

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

Suppliers and Packaging for NDA: 075776

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 075776 ANDA IVAX Pharmaceuticals, Inc. 0172-5032 0172-5032-60 100 TABLET in 1 BOTTLE (0172-5032-60)
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 075776 ANDA IVAX Pharmaceuticals, Inc. 0172-5032 0172-5032-70 500 TABLET in 1 BOTTLE (0172-5032-70)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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