Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hikma Pharmaceuticals USA Inc.
West-Ward Pharmaceuticals Corp.
946499746
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sufentanil Citrate
Product Details
NDC Product Code
0641-6110Application Number
ANDA074413Marketing Category
ANDA (C73584)Route of Administration
EPIDURAL, INTRAVENOUSEffective Date
September 17, 2018WATERInactive
Code: 059QF0KO0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SufentanilActive
Code: S9ZFX8403RClass: ACTIMQuantity: 0.05 mg in 1 mL
Sufentanil Citrate
Product Details
NDC Product Code
0641-6112Application Number
ANDA074413Marketing Category
ANDA (C73584)Route of Administration
EPIDURAL, INTRAVENOUSEffective Date
September 17, 2018SufentanilActive
Code: S9ZFX8403RClass: ACTIMQuantity: 0.05 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Sufentanil Citrate
Product Details
NDC Product Code
0641-6111Application Number
ANDA074413Marketing Category
ANDA (C73584)Route of Administration
EPIDURAL, INTRAVENOUSEffective Date
September 17, 2018CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SufentanilActive
Code: S9ZFX8403RClass: ACTIMQuantity: 0.05 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT