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Generated: November 18, 2018

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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 four 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. Five 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
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 0677-1978-01 1 BOTTLE in 1 CARTON (0677-1978-01) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356 NDA AUTHORIZED GENERIC United Research Laboratories, Inc. 0677-1979 0677-1979-01 1 BOTTLE in 1 CARTON (0677-1979-01) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

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EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EXTENDED RELEASE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EXTENDED RELEASE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 ➤ Sign Up ➤ Sign Up
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008 ➤ Sign Up ➤ Sign Up
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-001 Feb 2, 1995 ➤ Sign Up ➤ Sign Up
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995 ➤ Sign Up ➤ Sign Up
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-006 Jan 2, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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