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FDA Approval

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

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

FDA Approval Summary

Company
Effective Date
August 26, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Piperacillin(3 g in 100 mL)
Tazobactam(375 mg in 100 mL)

Products3

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

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product Details

NDC Product Code
70594-079
Application Number
ANDA212287
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 26, 2022
Code: M98T69Q7HPClass: ACTIMQuantity: 3 g in 100 mL
Code: UXA545ABTTClass: ACTIMQuantity: 375 mg in 100 mL

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product Details

NDC Product Code
70594-080
Application Number
ANDA212287
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 26, 2022
Code: M98T69Q7HPClass: ACTIMQuantity: 4 g in 150 mL
Code: UXA545ABTTClass: ACTIMQuantity: 500 mg in 150 mL

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product Details

NDC Product Code
70594-078
Application Number
ANDA212287
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 26, 2022
Code: M98T69Q7HPClass: ACTIMQuantity: 2 g in 50 mL
Code: UXA545ABTTClass: ACTIMQuantity: 250 mg in 50 mL
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