Details for New Drug Application (NDA): 020356

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NDA 020356 describes SULAR, which is a drug marketed by Covis and is included in one NDA. It is available from two 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. Four suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.

Summary for 020356

Tradename:	SULAR
Applicant:	Covis
Ingredient:	nisoldipine
Patents:	0

Pharmacology for NDA: 020356

Mechanism of Action	Calcium Channel Antagonists
Physiological Effect	Decreased Blood Pressure

Medical Subject Heading (MeSH) Categories for 020356

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

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	Prasco Laboratories	66993-472	66993-472-02	1 BOTTLE in 1 CARTON (66993-472-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-473	66993-473-02	1 BOTTLE in 1 CARTON (66993-473-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 1995	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020356

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-006	Jan 2, 2008	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-001	Feb 2, 1995	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008	⤷ Sign Up	⤷ Sign Up
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