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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202554

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NDA 202554 describes LISINOPRIL, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo, Casi Pharms Inc, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, Watson Labs, and Wockhardt, and is included in thirty-one NDAs. It is available from seventy-eight suppliers. Additional details are available on the LISINOPRIL profile page.

The generic ingredient in LISINOPRIL is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 202554
Tradename:LISINOPRIL
Applicant:Accord Hlthcare
Ingredient:lisinopril
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202554
Medical Subject Heading (MeSH) Categories for 202554
Suppliers and Packaging for NDA: 202554
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL lisinopril TABLET;ORAL 202554 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7966 N 0615-7966-05
LISINOPRIL lisinopril TABLET;ORAL 202554 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7966 N 0615-7966-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jul 30, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 30, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 30, 2013TE:ABRLD:No

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