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Details for New Drug Application (NDA): 205435

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NDA 205435 describes SIVEXTRO, which is a drug marketed by Cubist Pharms Llc and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SIVEXTRO profile page.

The generic ingredient in SIVEXTRO is tedizolid phosphate. One supplier is listed for this compound. Additional details are available on the tedizolid phosphate profile page.

Summary for NDA: 205435

Tradename:
SIVEXTRO
Applicant:
Cubist Pharms Llc
Ingredient:
tedizolid phosphate
Patents:3

Pharmacology for NDA: 205435

Ingredient-typeOxazolidinones

Suppliers and Packaging for NDA: 205435

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIVEXTRO
tedizolid phosphate
TABLET;ORAL 205435 NDA Merck Sharp & Dohme Corp. 67919-041 67919-041-01 30 TABLET, FILM COATED in 1 BOTTLE (67919-041-01)
SIVEXTRO
tedizolid phosphate
TABLET;ORAL 205435 NDA Merck Sharp & Dohme Corp. 67919-041 67919-041-02 1 BLISTER PACK in 1 CARTON (67919-041-02) > 6 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 20, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 20, 2024
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Patent:7,816,379Patent Expiration:Feb 23, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:8,420,676Patent Expiration:Feb 23, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS


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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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