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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 077606

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NDA 077606 describes LISINOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Mylan, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from thirty-one suppliers. Additional details are available on the LISINOPRIL AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in LISINOPRIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 077606
Pharmacology for NDA: 077606
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 077606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077606 ANDA Aurobindo Pharma Limited 65862-043 65862-043-00 100 TABLET in 1 BOTTLE (65862-043-00)
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077606 ANDA Aurobindo Pharma Limited 65862-043 65862-043-01 100 TABLET in 1 BOTTLE (65862-043-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;10MG
Approval Date:Mar 14, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Mar 14, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;20MG
Approval Date:Mar 14, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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