Cefotan
CEFOTAN(Cefotetan for injection, USP)
Approved
Approval ID
0860bfe0-da3e-4460-da57-2411db14c426
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2018
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cefotetan disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-053
Application NumberNDA050588
Product Classification
M
Marketing Category
C73594
G
Generic Name
cefotetan disodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 27, 2018
FDA Product Classification
INGREDIENTS (1)
Cefotetan DisodiumActive
Quantity: 2 g in 20 mL
Code: 0GXP746VXB
Classification: ACTIM
Cefotetan Disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-052
Application NumberNDA050588
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cefotetan Disodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 27, 2018
FDA Product Classification
INGREDIENTS (1)
Cefotetan DisodiumActive
Quantity: 1 g in 10 mL
Code: 0GXP746VXB
Classification: ACTIM