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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203508

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NDA 203508 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 sixty-two 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. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 203508
Tradename:LISINOPRIL
Applicant:Invagen Pharms
Ingredient:lisinopril
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203508
Medical Subject Heading (MeSH) Categories for 203508
Suppliers and Packaging for NDA: 203508
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL lisinopril TABLET;ORAL 203508 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-009 N 43353-009-60
LISINOPRIL lisinopril TABLET;ORAL 203508 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-009 N 43353-009-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 29, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 29, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 29, 2013TE:ABRLD:No

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