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Generated: May 26, 2019

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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 205435
Applicant:Cubist Pharms Llc
Ingredient:tedizolid phosphate
Generic Entry Opportunity Date for 205435
Generic Entry Date for 205435*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 205435
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

Profile 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 Expiration:Jun 20, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Feb 23, 2028Product Flag?YSubstance Flag?YDelist Request?

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