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Details for New Drug Application (NDA): 050632

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NDA 050632 describes AZACTAM IN PLASTIC CONTAINER, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. Additional details are available on the AZACTAM IN PLASTIC CONTAINER profile page.

The generic ingredient in AZACTAM IN PLASTIC CONTAINER 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: 050632

Tradename:
AZACTAM IN PLASTIC CONTAINER
Applicant:
Bristol Myers Squibb
Ingredient:
aztreonam
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050632

Ingredient-typeMonobactams

Suppliers and Packaging for NDA: 050632

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACTAM IN PLASTIC CONTAINER
aztreonam
INJECTABLE;INJECTION 050632 NDA E.R. Squibb & Sons, L.L.C. 0003-2230 0003-2230-11 24 CONTAINER in 1 PACKAGE (0003-2230-11) > 50 mL in 1 CONTAINER
AZACTAM IN PLASTIC CONTAINER
aztreonam
INJECTABLE;INJECTION 050632 NDA E.R. Squibb & Sons, L.L.C. 0003-2240 0003-2240-11 24 CONTAINER in 1 PACKAGE (0003-2240-11) > 50 mL in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:May 24, 1989TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:May 24, 1989TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:May 24, 1989TE:RLD:No


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