FORTAZ
FORTAZ (ceftazidime for injection)
Approved
Approval ID
78982c98-7866-49f1-989f-a289c4242358
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2017
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
Products 3
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 Code52565-107
Application NumberNDA050578
Product Classification
M
Marketing Category
C73594
G
Generic Name
ceftazidime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 8, 2019
FDA Product Classification
INGREDIENTS (2)
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
CEFTAZIDIMEActive
Quantity: 170 mg in 1 mL
Code: 9M416Z9QNR
Classification: ACTIM
ceftazidime
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-106
Application NumberNDA050578
Product Classification
M
Marketing Category
C73594
G
Generic Name
ceftazidime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 8, 2019
FDA Product Classification
INGREDIENTS (2)
CEFTAZIDIMEActive
Quantity: 100 mg in 1 mL
Code: 9M416Z9QNR
Classification: ACTIM
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ceftazidime
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-105
Application NumberNDA050578
Product Classification
M
Marketing Category
C73594
G
Generic Name
ceftazidime
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 8, 2019
FDA Product Classification
INGREDIENTS (2)
CEFTAZIDIMEActive
Quantity: 100 mg in 1 mL
Code: 9M416Z9QNR
Classification: ACTIM
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT