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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
QuintilesIMS
AstraZeneca
Healthtrust
Dow
Covington
Express Scripts
US Department of Justice
Julphar

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020356

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NDA 020356 describes SULAR, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from five suppliers. Additional details are available on the SULAR profile page.

The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 020356
Tradename:SULAR
Applicant:Covis Pharma Bv
Ingredient:nisoldipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020356
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Physiological EffectDecreased Blood Pressure
Medical Subject Heading (MeSH) Categories for 020356
Suppliers and Packaging for NDA: 020356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356 NDA AUTHORIZED GENERIC United Research Laboratories, Inc. 0677-1978 E 0677-1978-01
SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356 NDA AUTHORIZED GENERIC United Research Laboratories, Inc. 0677-1979 E 0677-1979-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 1995TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 1995TE:RLD:Yes

Expired US Patents for NDA 020356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-002 Feb 2, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-001 Feb 2, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Merck
Moodys
Fish and Richardson
Citi
Harvard Business School
Baxter
US Army

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