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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077022

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NDA 077022 describes CILOSTAZOL, which is a drug marketed by Breckenridge Pharm, Frontida Biopharm, Sandoz, Mylan Pharms Inc, Ivax Sub Teva Pharms, Chartwell Rx, Epic Pharma Llc, Mylan, West-ward Pharms Int, Teva, Actavis Elizabeth, Apotex Inc, and Pliva Hrvatska Doo, and is included in sixteen NDAs. It is available from sixteen suppliers. Additional details are available on the CILOSTAZOL profile page.

The generic ingredient in CILOSTAZOL is cilostazol. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cilostazol profile page.

Summary for 077022

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 077022

Suppliers and Packaging for NDA: 077022

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CILOSTAZOL
cilostazol
TABLET;ORAL 077022 ANDA STAT RX USA LLC 16590-285 16590-285-30 30 TABLET in 1 BOTTLE (16590-285-30)
CILOSTAZOL
cilostazol
TABLET;ORAL 077022 ANDA STAT RX USA LLC 16590-285 16590-285-60 60 TABLET in 1 BOTTLE (16590-285-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Nov 23, 2004TE:RLD:No


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McKinsey
Federal Trade Commission
Accenture

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