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FDA Approval

Vazculep

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

FDA Approval Summary

Company
Effective Date
March 26, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine(10 mg in 1 mL)

Manufacturing Establishments1

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

Exela Pharma Sciences, LLC

Exela Phrama Sciences, LLC

831274399

Products3

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

Vazculep

Product Details

NDC Product Code
51754-4020
Application Number
NDA204300
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
March 26, 2021
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

Vazculep

Product Details

NDC Product Code
51754-4010
Application Number
NDA204300
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
March 26, 2021
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Vazculep

Product Details

NDC Product Code
51754-4000
Application Number
NDA204300
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
March 26, 2021
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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