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Details for New Drug Application (NDA): 065439

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NDA 065439 describes AZTREONAM, which is a drug marketed by Fresenius Kabi Usa and West-ward Pharms Int and is included in two NDAs. It is available from one supplier. 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. Four suppliers are listed for this compound. Additional details are available on the aztreonam profile page.

Summary for NDA: 065439

Tradename:
AZTREONAM
Applicant:
Fresenius Kabi Usa
Ingredient:
aztreonam
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065439

Ingredient-typeMonobactams

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
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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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