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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019888

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NDA 019888 describes ZESTORETIC, which is a drug marketed by Alvogen Malta and is included in one NDA. It is available from two suppliers. Additional details are available on the ZESTORETIC profile page.

The generic ingredient in ZESTORETIC is hydrochlorothiazide; lisinopril. There are thirty-one drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for NDA: 019888

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

Pharmacology for NDA: 019888

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

Suppliers and Packaging for NDA: 019888

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL 019888 NDA AstraZeneca Pharmaceuticals LP 0310-0141 0310-0141-11 100 TABLET in 1 BOTTLE (0310-0141-11)
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL 019888 NDA AstraZeneca Pharmaceuticals LP 0310-0142 0310-0142-11 100 TABLET in 1 BOTTLE (0310-0142-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Sep 20, 1990TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;20MG
Approval Date:Jul 20, 1989TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;10MG
Approval Date:Nov 18, 1993TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019888

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL019888-002Jul 20, 1989► Subscribe► Subscribe
Alvogen Malta
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL019888-003Nov 18, 1993► Subscribe► Subscribe
Alvogen Malta
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL019888-001Sep 20, 1990► Subscribe► Subscribe
Alvogen Malta
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL019888-003Nov 18, 1993► Subscribe► Subscribe
Alvogen Malta
ZESTORETIC
hydrochlorothiazide; lisinopril
TABLET;ORAL019888-001Sep 20, 1990► Subscribe► Subscribe
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Medtronic
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