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Aggrenox

These highlights do not include all the information needed to use AGGRENOX safely and effectively. See full prescribing information for AGGRENOX. AGGRENOX® (aspirin/extended-release dipyridamole) CapsulesInitial U.S. Approval: 1999

Approved
Approval ID

f07c8535-f9fb-4697-9b63-1ab22210efc9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 6, 2016

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

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

aspirin and dipyridamole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-3971
Application NumberNDA020884
Product Classification
M
Marketing Category
C73594
G
Generic Name
aspirin and dipyridamole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2016
FDA Product Classification

INGREDIENTS (2)

DIPYRIDAMOLEActive
Quantity: 200 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
ASPIRINActive
Quantity: 25 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB

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Aggrenox - FDA Drug Approval Details