| Product NDC: | 68712-027 |
| Proprietary Name: | CNL8 |
| Non Proprietary Name: | Ciclopirox |
| Active Ingredient(s): | 2.28 g/mL & nbsp; Ciclopirox |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68712-027 |
| Labeler Name: | Innocutis Holdings LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078270 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20081031 |
| Package NDC: | 68712-027-03 |
| Package Description: | 5 mL in 1 BOTTLE, GLASS (68712-027-03) |
| NDC Code | 68712-027-03 |
| Proprietary Name | CNL8 |
| Package Description | 5 mL in 1 BOTTLE, GLASS (68712-027-03) |
| Product NDC | 68712-027 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ciclopirox |
| Dosage Form Name | SOLUTION |
| Route Name | TOPICAL |
| Start Marketing Date | 20081031 |
| Marketing Category Name | ANDA |
| Labeler Name | Innocutis Holdings LLC |
| Substance Name | CICLOPIROX |
| Strength Number | 2.28 |
| Strength Unit | g/mL |
| Pharmaceutical Classes | Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] |