Details for New Drug Application (NDA): 077364

NDA 077364 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 077364

Tradename:	CICLOPIROX
Applicant:	Padagis Israel
Ingredient:	ciclopirox
Patents:	0

Pharmacology for NDA: 077364

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

Suppliers and Packaging for NDA: 077364

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CICLOPIROX	ciclopirox	CREAM;TOPICAL	077364	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-138	45802-138-11	1 TUBE in 1 CARTON (45802-138-11) / 30 g in 1 TUBE
CICLOPIROX	ciclopirox	CREAM;TOPICAL	077364	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-138	45802-138-18	1 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.77%
Approval Date:	Mar 3, 2006	TE:	AB	RLD:	No

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