Details for New Drug Application (NDA): 078463
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NDA 078463 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.
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 078463
| Tradename: | CICLOPIROX |
| Applicant: | Cosette |
| Ingredient: | ciclopirox |
| Patents: | 0 |
Pharmacology for NDA: 078463
| Mechanism of Action | Protein Synthesis Inhibitors |
| Physiological Effect | Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication |
Suppliers and Packaging for NDA: 078463
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CICLOPIROX | ciclopirox | CREAM;TOPICAL | 078463 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0638 | 0713-0638-15 | 1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE |
| CICLOPIROX | ciclopirox | CREAM;TOPICAL | 078463 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0638 | 0713-0638-18 | 1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.77% | ||||
| Approval Date: | Dec 20, 2010 | TE: | AB | RLD: | No | ||||
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