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FDA Approval

BRIDION

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

FDA Approval Summary

Company
Effective Date
December 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sugammadex(100 mg in 1 mL)

Products2

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

BRIDION

Product Details

NDC Product Code
0006-5423
Application Number
NDA022225
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 17, 2022
Code: ERJ6X2MXV7Class: ACTIMQuantity: 100 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

BRIDION

Product Details

NDC Product Code
0006-5425
Application Number
NDA022225
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 17, 2022
Code: ERJ6X2MXV7Class: ACTIMQuantity: 100 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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BRIDION - FDA Approval | MedPath