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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
Farmers Insurance
US Department of Justice
Daiichi Sankyo

Generated: December 14, 2017

DrugPatentWatch Database Preview

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 one supplier. 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. Three suppliers are listed for this compound. Additional details are available on the aztreonam profile page.

Summary for 050580

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050580


Medical Subject Heading (MeSH) Categories for 050580

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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Serving leading biopharmaceutical companies globally:

Fish and Richardson

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