Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204058

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NDA 204058 describes LISINOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Inc, Aurobindo, 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-three 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-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 204058
Pharmacology for NDA: 204058
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 204058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 204058 ANDA Exelan Pharmaceuticals, Inc. 76282-446 76282-446-01 100 TABLET in 1 BOTTLE (76282-446-01)
LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 204058 ANDA Exelan Pharmaceuticals, Inc. 76282-446 76282-446-05 500 TABLET in 1 BOTTLE (76282-446-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;10MG
Approval Date:May 23, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:May 23, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;20MG
Approval Date:May 23, 2017TE:ABRLD:No

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