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Last Updated: November 15, 2024

Details for New Drug Application (NDA): 050634


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NDA 050634 describes FORTAZ IN PLASTIC CONTAINER, which is a drug marketed by Pai Holdings Pharm and is included in one NDA. Additional details are available on the FORTAZ IN PLASTIC CONTAINER profile page.

The generic ingredient in FORTAZ IN PLASTIC CONTAINER is ceftazidime sodium. There are seventeen drug master file entries for this compound. Additional details are available on the ceftazidime sodium profile page.
Summary for 050634
Tradename:FORTAZ IN PLASTIC CONTAINER
Applicant:Pai Holdings Pharm
Ingredient:ceftazidime sodium
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Apr 28, 1989TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/ML
Approval Date:Apr 28, 1989TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Apr 28, 1989TE:RLD:Yes

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