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Generated: June 26, 2019

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Details for New Drug Application (NDA): 206829

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NDA 206829 describes ZERBAXA, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZERBAXA profile page.

The generic ingredient in ZERBAXA is ceftolozane sulfate; tazobactam sodium. One supplier is listed for this compound. Additional details are available on the ceftolozane sulfate; tazobactam sodium profile page.
Summary for 206829
Tradename:ZERBAXA
Applicant:Cubist Pharms Llc
Ingredient:ceftolozane sulfate; tazobactam sodium
Patents:8
Generic Entry Opportunity Date for 206829
Generic Entry Date for 206829*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;IV (INFUSION)

*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: 206829
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 206829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829 NDA Merck Sharp & Dohme Corp. 67919-030 67919-030-01 10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
Approval Date:Dec 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2024
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2035Product Flag?YSubstance Flag?Delist Request?

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