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Corlopam

These highlights do not include all the information needed to use CORLOPAM safely and effectively. See full prescribing information for CORLOPAM. CORLOPAM (fenoldopam mesylate) injection, for intravenous use Initial U.S. Approval: 1997

Approved
Approval ID

df4cd207-c3b8-4008-5290-02f296c2b4a6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 10, 2021

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 1

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

fenoldopam mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-3373
Application NumberNDA019922
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenoldopam mesylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 2021
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
FENOLDOPAM MESYLATEActive
Quantity: 10 mg in 1 mL
Code: HA3R0MY016
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Quantity: 3.44 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 518 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 1 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.61 mg in 1 mL
Code: B22547B95K
Classification: IACT

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Corlopam - FDA Drug Approval Details