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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 Shionogi Inc 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 NDA: 020356

Tradename:
SULAR
Applicant:
Shionogi Inc
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

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

Summary 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EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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EXTENDED RELEASE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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EXTENDED RELEASE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Expired Orange Book Patents for NDA: 020356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc
SULAR
nisoldipine
TABLET, EXTENDED RELEASE;ORAL020356-003Feb 2, 19954,703,038► subscribe
Shionogi Inc
SULAR
nisoldipine
TABLET, EXTENDED RELEASE;ORAL020356-004Feb 2, 19954,703,038► subscribe
Shionogi Inc
SULAR
nisoldipine
TABLET, EXTENDED RELEASE;ORAL020356-008Jan 2, 20085,422,123► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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