Details for New Drug Application (NDA): 078172

NDA 078172 describes CICLOPIROX, which is a drug marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Alvogen, Glenmark Pharms Inc, Padagis Us, Actavis Mid Atlantic, Encube, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, Taro Pharm Inds, and Teva Pharms, and is included in twenty-eight NDAs. It is available from fifteen suppliers. Additional details are available on the CICLOPIROX profile page.

The generic ingredient in CICLOPIROX 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 078172

Tradename:	CICLOPIROX
Applicant:	Acella
Ingredient:	ciclopirox
Patents:	0

Pharmacology for NDA: 078172

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

Suppliers and Packaging for NDA: 078172

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078172	ANDA	Acella Pharmaceuticals, LLC	42192-715	42192-715-06	1 BOTTLE in 1 CARTON (42192-715-06) / 6.6 mL in 1 BOTTLE
CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078172	ANDA	A-S Medication Solutions	50090-6562	50090-6562-0	1 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	8%
Approval Date:	Sep 18, 2007	TE:	AT	RLD:	No

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