Details for New Drug Application (NDA): 019824

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NDA 019824 describes LOPROX, which is a drug marketed by Medimetriks Pharms and Bausch 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. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for 019824

Tradename:	LOPROX
Applicant:	Medimetriks Pharms
Ingredient:	ciclopirox
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019824

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

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;TOPICAL			Strength	0.77%
Approval Date:	Dec 30, 1988	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019824

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medimetriks Pharms	LOPROX	ciclopirox	SUSPENSION;TOPICAL	019824-001	Dec 30, 1988	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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