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Cefotetan

Cefotetan for Injection, USP

Approved
Approval ID

bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2020

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

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 Code63323-386
Application NumberANDA065374
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFOTETAN DISODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 30, 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 Code63323-385
Application NumberANDA065374
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFOTETAN DISODIUM
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 30, 2018
FDA Product Classification

INGREDIENTS (1)

CEFOTETAN DISODIUMActive
Quantity: 1 g in 10 mL
Code: 0GXP746VXB
Classification: ACTIM

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Cefotetan - FDA Drug Approval Details