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Details for New Drug Application (NDA): 050634

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NDA 050634 describes FORTAZ IN PLASTIC CONTAINER, which is a drug marketed by Igi Labs Inc and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the ceftazidime sodium profile page.

Summary for NDA: 050634

Tradename:
FORTAZ IN PLASTIC CONTAINER
Applicant:
Igi Labs Inc
Ingredient:
ceftazidime sodium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050634

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 050634

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTAZ IN PLASTIC CONTAINER
ceftazidime sodium
INJECTABLE;INJECTION 050634 NDA Covis Pharmaceuticals, Inc. 24987-412 24987-412-00 24 CONTAINER in 1 CARTON (24987-412-00) > 50 mL in 1 CONTAINER
FORTAZ IN PLASTIC CONTAINER
ceftazidime sodium
INJECTABLE;INJECTION 050634 NDA Covis Pharmaceuticals, Inc. 24987-413 24987-413-00 24 CONTAINER in 1 CARTON (24987-413-00) > 50 mL in 1 CONTAINER

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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