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FDA Approval

Ampicillin and Sulbactam

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

FDA Approval Summary

Company
WG Critical Care, LLC
DUNS: 829274633
Effective Date
February 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ceftriaxone(1 g in 20 mL)
Ampicillin(2 g in 20 mL)

Products2

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

Ampicillin and Sulbactam

Product Details

NDC Product Code
44567-211
Application Number
ANDA065176
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
February 23, 2023
Code: DKQ4T82YE6Class: ACTIMQuantity: 1 g in 20 mL
Code: JFN36L5S8KClass: ACTIMQuantity: 2 g in 20 mL
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 20 mL

Ampicillin and Sulbactam

Product Details

NDC Product Code
44567-210
Application Number
ANDA065176
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
February 23, 2023
Code: JFN36L5S8KClass: ACTIMQuantity: 1 g in 10 mL
Code: DKQ4T82YE6Class: ACTIMQuantity: 0.5 g in 10 mL
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 10 mL
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