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Last Updated: July 22, 2024

Details for New Drug Application (NDA): 021159

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NDA 021159 describes LOPROX, which is a drug marketed by Medimetriks Pharms and Bausch and is included in three NDAs. It is available from one supplier. 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. Sixteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 021159
Formulation / Manufacturing:see details
Pharmacology for NDA: 021159
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 Bausch Health US, LLC 99207-010 99207-010-10 1 BOTTLE, PLASTIC in 1 CARTON (99207-010-10) / 120 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

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

Expired US Patents for NDA 021159

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ⤷  Sign Up ⤷  Sign Up
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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