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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Fish and Richardson
Queensland Health
Boehringer Ingelheim

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019824

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NDA 019824 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 019824

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019824

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPROX ciclopirox SUSPENSION;TOPICAL 019824 NDA Medimetriks Pharmaceuticals, Inc. 43538-550 43538-550-60 1 BOTTLE in 1 CARTON (43538-550-60) > 60 mL in 1 BOTTLE
LOPROX ciclopirox SUSPENSION;TOPICAL 019824 NDA Medimetriks Pharmaceuticals, Inc. 43538-551 43538-551-60 1 KIT in 1 CARTON (43538-551-60) * 60 mL in 1 BOTTLE * 454 g in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.77%
Approval Date:Dec 30, 1988TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019824

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks PharmsLOPROXciclopiroxSUSPENSION;TOPICAL019824-001Dec 30, 1988► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Cantor Fitzgerald

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