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

Tradename:	LOPROX
Applicant:	Bausch
Ingredient:	ciclopirox
Patents:	0

Pharmacology for NDA: 021159

Mechanism of Action	Protein Synthesis Inhibitors
Physiological Effect	Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication

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:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	1%
Approval Date:	Feb 28, 2003	TE:	AT	RLD:	Yes

Expired US Patents for NDA 021159

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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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