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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 065439


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NDA 065439 describes AZTREONAM, which is a drug marketed by Fresenius Kabi Usa, Hikma, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the AZTREONAM profile page.

The generic ingredient in AZTREONAM is aztreonam. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aztreonam profile page.
Summary for 065439
Tradename:AZTREONAM
Applicant:Fresenius Kabi Usa
Ingredient:aztreonam
Patents:0
Pharmacology for NDA: 065439
Medical Subject Heading (MeSH) Categories for 065439
Anti-Bacterial Agents
Suppliers and Packaging for NDA: 065439
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZTREONAM aztreonam INJECTABLE;INJECTION 065439 ANDA Fresenius Kabi USA, LLC 63323-401 63323-401-26 10 VIAL in 1 TRAY (63323-401-26) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-21)
AZTREONAM aztreonam INJECTABLE;INJECTION 065439 ANDA Fresenius Kabi USA, LLC 63323-401 63323-401-24 10 VIAL in 1 TRAY (63323-401-24) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Jun 18, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Jun 18, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/VIAL
Approval Date:Jun 18, 2010TE:APRLD:No

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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