Details for New Drug Application (NDA): 019777

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NDA 019777 describes ZESTRIL, which is a drug marketed by Twi Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ZESTRIL profile page.

The generic ingredient in ZESTRIL is lisinopril. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the lisinopril profile page.

Summary for 019777

Tradename:	ZESTRIL
Applicant:	Twi Pharms
Ingredient:	lisinopril
Patents:	0

Pharmacology for NDA: 019777

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for 019777

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents

Suppliers and Packaging for NDA: 019777

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-238	24979-238-07	90 TABLET in 1 BOTTLE (24979-238-07)
ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-239	24979-239-07	90 TABLET in 1 BOTTLE (24979-239-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 19, 1988	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 19, 1988	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 19, 1988	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019777

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-005	Apr 29, 1993	4,374,829*PED	⤷ Get Started Free
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-006	Jan 20, 1999	4,374,829*PED	⤷ Get Started Free
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-004	May 19, 1988	4,374,829*PED	⤷ Get Started Free
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-003	May 19, 1988	4,374,829*PED	⤷ Get Started Free
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-001	May 19, 1988	4,374,829*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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