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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 019777


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NDA 019777 describes ZESTRIL, which is a drug marketed by Almatica 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. Forty-four suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
Summary for 019777
Tradename:ZESTRIL
Applicant:Almatica
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 LLC 52427-438 52427-438-90 90 TABLET in 1 BOTTLE (52427-438-90)
ZESTRIL lisinopril TABLET;ORAL 019777 NDA Almatica Pharma LLC 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
Almatica ZESTRIL lisinopril TABLET;ORAL 019777-005 Apr 29, 1993 See Plans and Pricing See Plans and Pricing
Almatica ZESTRIL lisinopril TABLET;ORAL 019777-003 May 19, 1988 See Plans and Pricing See Plans and Pricing
Almatica ZESTRIL lisinopril TABLET;ORAL 019777-002 May 19, 1988 See Plans and Pricing See Plans and Pricing
Almatica ZESTRIL lisinopril TABLET;ORAL 019777-006 Jan 20, 1999 See Plans and Pricing See Plans and Pricing
Almatica ZESTRIL lisinopril TABLET;ORAL 019777-001 May 19, 1988 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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