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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021130

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NDA 021130 describes ZYVOX, which is a drug marketed by Pharmacia And Upjohn and is included in three NDAs. It is available from eight suppliers. There are two patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ZYVOX profile page.

The generic ingredient in ZYVOX is linezolid. There are twenty-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for 021130

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021130

Ingredient-typeOxazolidinones

Medical Subject Heading (MeSH) Categories for 021130

Suppliers and Packaging for NDA: 021130

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYVOX
linezolid
TABLET;ORAL 021130 NDA Pharmacia and Upjohn Company LLC 0009-5135 0009-5135-01 100 TABLET, FILM COATED in 1 BOTTLE (0009-5135-01)
ZYVOX
linezolid
TABLET;ORAL 021130 NDA Pharmacia and Upjohn Company LLC 0009-5135 0009-5135-02 20 TABLET, FILM COATED in 1 BOTTLE (0009-5135-02)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 18, 2000TE:RLD:Yes
Patent:► SubscribePatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Apr 18, 2000TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 2000► Subscribe► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Colorcon
UBS
Chinese Patent Office
Baxter
AstraZeneca
US Army
Fuji
QuintilesIMS

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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