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FDA Approval

Ceftriaxone

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

FDA Approval Summary

Company
Effective Date
April 7, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ceftriaxone(250 mg in 1 1)

Products4

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

Ceftriaxone

Product Details

NDC Product Code
70594-094
Application Number
ANDA091049
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
April 7, 2022
Code: 023Z5BR09KClass: ACTIMQuantity: 250 mg in 1 1

Ceftriaxone

Product Details

NDC Product Code
70594-095
Application Number
ANDA091049
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
April 7, 2022
Code: 023Z5BR09KClass: ACTIMQuantity: 500 mg in 1 1

Ceftriaxone

Product Details

NDC Product Code
70594-097
Application Number
ANDA091049
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
April 7, 2022
Code: 023Z5BR09KClass: ACTIMQuantity: 2 g in 1 1

Ceftriaxone

Product Details

NDC Product Code
70594-096
Application Number
ANDA091049
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
April 7, 2022
Code: 023Z5BR09KClass: ACTIMQuantity: 1 g in 1 1
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