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Generated: February 15, 2019

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Details for New Drug Application (NDA): 021159

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NDA 021159 describes LOPROX, which is a drug marketed by Medimetriks Pharms and Medicis and is included in three NDAs. It is available from three suppliers. 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-two suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 021159
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPROX ciclopirox SHAMPOO;TOPICAL 021159 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0522 0168-0522-04 1 BOTTLE, PLASTIC in 1 CARTON (0168-0522-04) > 120 mL in 1 BOTTLE, PLASTIC
LOPROX ciclopirox SHAMPOO;TOPICAL 021159 NDA Valeant Pharmaceuticals North America LLC 99207-010 99207-010-01 6 BOTTLE, PLASTIC in 1 CARTON (99207-010-01) > 10 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength1%
Approval Date:Feb 28, 2003TE:ATRLD:Yes

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