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Generated: April 29, 2017

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Details for New Drug Application (NDA): 206392

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NDA 206392 describes ASPIRIN AND DIPYRIDAMOLE, which is a drug marketed by Barr, Sandoz Inc, Par Pharm Inc, Impax Labs Inc, and Amneal Pharms, and is included in five NDAs. It is available from three suppliers. Additional details are available on the ASPIRIN AND DIPYRIDAMOLE profile page.

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

Summary for NDA: 206392

Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206392

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
aspirin; dipyridamole
CAPSULE, EXTENDED RELEASE;ORAL 206392 ANDA Amneal Pharmaceuticals LLC 65162-596 65162-596-06 60 CAPSULE in 1 BOTTLE (65162-596-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG;200MG
Approval Date:Mar 8, 2016TE:ABRLD:No

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