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Generated: November 12, 2018

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Details for New Drug Application (NDA): 019777

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NDA 019777 describes ZESTRIL, 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 ZESTRIL profile page.

The generic ingredient in ZESTRIL is lisinopril. There are twenty-one drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
Summary for 019777
Tradename:ZESTRIL
Applicant:Alvogen Malta
Ingredient:lisinopril
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019777
Medical Subject Heading (MeSH) Categories for 019777
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 Almatica Pharma Inc. 52427-438 52427-438-90 90 TABLET in 1 BOTTLE (52427-438-90)
ZESTRIL lisinopril TABLET;ORAL 019777 NDA Almatica Pharma Inc. 52427-439 52427-439-90 90 TABLET in 1 BOTTLE (52427-439-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 19, 1988TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 19, 1988TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 19, 1988TE:ABRLD:Yes

Expired US Patents for NDA 019777

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta ZESTRIL lisinopril TABLET;ORAL 019777-005 Apr 29, 1993 ➤ Sign Up ➤ Sign Up
Alvogen Malta ZESTRIL lisinopril TABLET;ORAL 019777-003 May 19, 1988 ➤ Sign Up ➤ Sign Up
Alvogen Malta ZESTRIL lisinopril TABLET;ORAL 019777-004 May 19, 1988 ➤ Sign Up ➤ Sign Up
Alvogen Malta ZESTRIL lisinopril TABLET;ORAL 019777-002 May 19, 1988 ➤ Sign Up ➤ Sign Up
Alvogen Malta ZESTRIL lisinopril TABLET;ORAL 019777-001 May 19, 1988 ➤ Sign Up ➤ Sign Up
Alvogen Malta ZESTRIL lisinopril TABLET;ORAL 019777-006 Jan 20, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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