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Details for New Drug Application (NDA): 050580

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NDA 050580 describes AZACTAM, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. Additional details are available on the AZACTAM profile page.

The generic ingredient in AZACTAM 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: 050580

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

Pharmacology for NDA: 050580

Ingredient-typeMonobactams

Suppliers and Packaging for NDA: 050580

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACTAM
aztreonam
INJECTABLE;INJECTION 050580 NDA E.R. Squibb & Sons, L.L.C. 0003-2560 0003-2560-16 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2560-16) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
AZACTAM
aztreonam
INJECTABLE;INJECTION 050580 NDA E.R. Squibb & Sons, L.L.C. 0003-2570 0003-2570-16 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Dec 31, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Dec 31, 1986TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/VIAL
Approval Date:Dec 31, 1986TE:APRLD:Yes


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