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Details for New Drug Application (NDA): 077021

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NDA 077021 describes CILOSTAZOL, which is a drug marketed by Breckenridge Pharm, Frontida Biopharm, Sandoz, Mylan Pharms Inc, Ivax Sub Teva Pharms, Biokey, Corepharma, Mylan, Roxane, Teva, Actavis Elizabeth, Apotex Inc, and Pliva Hrvatska Doo, and is included in sixteen NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the cilostazol profile page.

Summary for NDA: 077021

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

Pharmacology for NDA: 077021

Suppliers and Packaging for NDA: 077021

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CILOSTAZOL
cilostazol
TABLET;ORAL 077021 ANDA Eon Labs, Inc. 0185-0223 0185-0223-05 500 TABLET in 1 BOTTLE (0185-0223-05)
CILOSTAZOL
cilostazol
TABLET;ORAL 077021 ANDA Eon Labs, Inc. 0185-0223 0185-0223-60 60 TABLET in 1 BOTTLE (0185-0223-60)

Summary for product number 001

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


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