MedPath

FORTAZ

FORTAZ (ceftazidime for injection)PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

Approved
Approval ID

8b55504e-38c5-fa0c-7766-ee68d38c041b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 20, 2017

Manufacturers
FDA

Teligent Pharma, Inc.

DUNS: 011036910

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ceftazidime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52565-109
Application NumberNDA050578
Product Classification
M
Marketing Category
C73594
G
Generic Name
ceftazidime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 12, 2019
FDA Product Classification

INGREDIENTS (2)

CEFTAZIDIMEActive
Quantity: 200 mg in 1 mL
Code: 9M416Z9QNR
Classification: ACTIM
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT

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FORTAZ - FDA Drug Approval Details