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Details for New Drug Application (NDA): 019824

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NDA 019824 describes LOPROX, which is a drug marketed by Cnty Line Pharms, Medimetriks Pharms, and Medicis, and is included in four NDAs. It is available from three suppliers. There are four 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 suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for NDA: 019824

Medimetriks Pharms
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks Pharms
SUSPENSION;TOPICAL019824-001Dec 30, 19883,883,545<subscribe>
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