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Sufentanil Citrate

These highlights do not include all the information needed to use SUFENTANIL CITRATE INJECTION, safely and effectively. See full prescribing information for SUFENTANIL CITRATE INJECTION.Sufentanil Citrate Injection, for intravenous and epidural use, CIIInitial U.S. Approval: 1984

Approved
Approval ID

52fc28b9-464a-4173-9d0d-000ed0dbf265

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 11, 2018

Manufacturers
FDA

West-Ward Pharmaceuticals Corp.

DUNS: 946499746

Products 3

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

Sufentanil Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0641-6110
Application NumberANDA074413
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sufentanil Citrate
Product Specifications
Route of AdministrationEPIDURAL, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SUFENTANIL CITRATEActive
Quantity: 0.05 mg in 1 mL
Code: S9ZFX8403R
Classification: ACTIM

Sufentanil Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0641-6112
Application NumberANDA074413
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sufentanil Citrate
Product Specifications
Route of AdministrationEPIDURAL, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification

INGREDIENTS (3)

SUFENTANIL CITRATEActive
Quantity: 0.05 mg in 1 mL
Code: S9ZFX8403R
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Sufentanil Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0641-6111
Application NumberANDA074413
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sufentanil Citrate
Product Specifications
Route of AdministrationEPIDURAL, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification

INGREDIENTS (3)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SUFENTANIL CITRATEActive
Quantity: 0.05 mg in 1 mL
Code: S9ZFX8403R
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Sufentanil Citrate - FDA Drug Approval Details