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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 six 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 NDA: 206829

Cubist Pharms Llc
ceftolozane sulfate; tazobactam sodium
Formulation / Manufacturing:see details

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
ceftolozane sulfate; tazobactam sodium
POWDER;IV (INFUSION) 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

Summary for product number 001

Approval Date:Dec 19, 2014TE:RLD:Yes
Patent:8,476,425Patent Expiration:Sep 27, 2032Product Flag?Substance Flag?YDelist Request?
Patent:8,906,898Patent Expiration:May 28, 2034Product Flag?YSubstance Flag?YDelist Request?
Patent:9,320,740Patent Expiration:Mar 14, 2034Product Flag?YSubstance Flag?Delist Request?

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