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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018748

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NDA 018748 describes LOPROX, which is a drug marketed by Medimetriks Pharms and Medicis and is included in three NDAs. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LOPROX profile page.

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

Summary for 018748

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 018748

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPROX
ciclopirox
CREAM;TOPICAL 018748 NDA Medimetriks Pharmaceuticals, Inc. 43538-540 43538-540-90 1 TUBE in 1 CARTON (43538-540-90) > 90 g in 1 TUBE
LOPROX
ciclopirox
CREAM;TOPICAL 018748 NDA Medimetriks Pharmaceuticals, Inc. 43538-541 43538-541-90 1 KIT in 1 CARTON (43538-541-90) * 90 g in 1 TUBE * 454 g in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.77%
Approval Date:Dec 30, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018748

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks Pharms
LOPROX
ciclopirox
CREAM;TOPICAL018748-001Dec 30, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

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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.

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