Details for New Drug Application (NDA): 078266
NDA 078266 describes CICLOPIROX, which is a drug marketed by Cosette Pharms Nc, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Alvogen, 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 fourteen suppliers. Additional details are available on the CICLOPIROX profile page.
The generic ingredient in CICLOPIROX is ciclopirox. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
The generic ingredient in CICLOPIROX is ciclopirox. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 078266
| Tradename: | CICLOPIROX |
| Applicant: | Padagis Us |
| Ingredient: | ciclopirox |
| Patents: | 0 |
Pharmacology for NDA: 078266
| Mechanism of Action | Protein Synthesis Inhibitors |
| Physiological Effect | Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication |
Suppliers and Packaging for NDA: 078266
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CICLOPIROX | ciclopirox | GEL;TOPICAL | 078266 | ANDA | Padagis US LLC | 0574-2061 | 0574-2061-01 | 1 TUBE in 1 CARTON (0574-2061-01) / 100 g in 1 TUBE |
| CICLOPIROX | ciclopirox | GEL;TOPICAL | 078266 | ANDA | Padagis US LLC | 0574-2061 | 0574-2061-30 | 1 TUBE in 1 CARTON (0574-2061-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.77% | ||||
| Approval Date: | Jan 7, 2009 | TE: | AB | RLD: | No | ||||
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