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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chubb
Baxter
US Army
QuintilesIMS
Harvard Business School
Farmers Insurance
UBS
Moodys
Julphar

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078402

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NDA 078402 describes LISINOPRIL, which is a drug marketed by Apotex Inc, Wockhardt, Sandoz, Invagen Pharms, Lupin, Aurobindo, Prinston Inc, Sun Pharm Inds Ltd, Ivax Sub Teva Pharms, Accord Hlthcare, Watson Labs, Hikma Intl Pharms, Mylan, and Teva, and is included in thirty-one NDAs. It is available from seventy-five suppliers. Additional details are available on the LISINOPRIL profile page.

The generic ingredient in LISINOPRIL is hydrochlorothiazide; lisinopril. There are thirty-one drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for NDA: 078402

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078402

Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 078402

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISINOPRIL
lisinopril
TABLET;ORAL 078402 ANDA Liberty Pharmaceuticals, Inc. 0440-7674 0440-7674-90 90 TABLET in 1 BOTTLE, PLASTIC (0440-7674-90)
LISINOPRIL
lisinopril
TABLET;ORAL 078402 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7639 0615-7639-31 31 TABLET, FILM COATED in 1 BLISTER PACK (0615-7639-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Apr 19, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 19, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 19, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
US Department of Justice
Johnson and Johnson
Covington
Healthtrust
Fish and Richardson
QuintilesIMS
Mallinckrodt
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Baxter

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