Details for New Drug Application (NDA): 077364
✉ Email this page to a colleague
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 |
Complete Access Available with Subscription