MedPath
FDA Approval

CEFOTAXIME

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
WOCKHARDT LIMITED
DUNS: 650069115
Effective Date
October 19, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cefotaxime(1 g in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

WOCKHARDT LIMITED

WOCKHARDT LIMITED

915122332

Products3

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

CEFOTAXIME

Product Details

NDC Product Code
55648-986
Application Number
ANDA065197
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
November 20, 2009
Code: 258J72S7TZClass: ACTIBQuantity: 1 g in 1 mL

CEFOTAXIME

Product Details

NDC Product Code
55648-947
Application Number
ANDA065197
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
November 20, 2009
Code: 258J72S7TZClass: ACTIBQuantity: 500 mg in 1 mL

CEFOTAXIME

Product Details

NDC Product Code
55648-948
Application Number
ANDA065197
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
November 20, 2009
Code: 258J72S7TZClass: ACTIBQuantity: 2 g in 1 mL
© Copyright 2025. All Rights Reserved by MedPath