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Details for New Drug Application (NDA): 020884

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NDA 020884 describes AGGRENOX, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from six suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the AGGRENOX profile page.

The generic ingredient in AGGRENOX is aspirin; dipyridamole. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the aspirin; dipyridamole profile page.

Summary for NDA: 020884

Tradename:
AGGRENOX
Applicant:
Boehringer Ingelheim
Ingredient:
aspirin; dipyridamole
Patents:1
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020884

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AGGRENOX
aspirin; dipyridamole
CAPSULE, EXTENDED RELEASE;ORAL 020884 NDA AUTHORIZED GENERIC Roxane Laboratories, Inc. 0054-0575 0054-0575-21 1 BOTTLE in 1 CARTON (0054-0575-21) > 60 CAPSULE in 1 BOTTLE
AGGRENOX
aspirin; dipyridamole
CAPSULE, EXTENDED RELEASE;ORAL 020884 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3040 0093-3040-06 1 BOTTLE in 1 CARTON (0093-3040-06) > 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG;200MG
Approval Date:Nov 22, 1999TE:ABRLD:Yes
Patent:6,015,577Patent Expiration:Jan 18, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE BRAIN OR COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS


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