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Details for New Drug Application (NDA): 078594

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NDA 078594 describes CICLOPIROX, which is a drug marketed by Fougera Pharms, Perrigo New York, Cipla Ltd, G And W Labs, Taro Pharm Inds, Actavis Mid Atlantic, G And W Labs Inc, Perrigo, Paddock Llc, Mylan Pharms Inc, Taro, Hi Tech Pharma, Apotex Inc, Glenmark Pharms, Akorn, Teva Pharms, Tolmar, and Glenmark Generics, and is included in twenty-six NDAs. It is available from nineteen suppliers. Additional details are available on the CICLOPIROX profile page.

The generic ingredient in CICLOPIROX is ciclopirox. There are ten drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for NDA: 078594

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078594

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SHAMPOO;TOPICAL 078594 ANDA Perrigo New York Inc 45802-401 45802-401-09 1 BOTTLE in 1 CARTON (45802-401-09) > 120 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength1%
Approval Date:Feb 16, 2010TE:ATRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.