| Product NDC: | 0462-0348 |
| Proprietary Name: | Zazole |
| Non Proprietary Name: | TERCONAZOLE |
| Active Ingredient(s): | 80 mg/1 & nbsp; TERCONAZOLE |
| Administration Route(s): | VAGINAL |
| Dosage Form(s): | SUPPOSITORY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0462-0348 |
| Labeler Name: | PharmaDerm a division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076850 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20060712 |
| Package NDC: | 0462-0348-03 |
| Package Description: | 1 DOSE PACK in 1 CARTON (0462-0348-03) > 3 SUPPOSITORY in 1 DOSE PACK |
| NDC Code | 0462-0348-03 |
| Proprietary Name | Zazole |
| Package Description | 1 DOSE PACK in 1 CARTON (0462-0348-03) > 3 SUPPOSITORY in 1 DOSE PACK |
| Product NDC | 0462-0348 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | TERCONAZOLE |
| Dosage Form Name | SUPPOSITORY |
| Route Name | VAGINAL |
| Start Marketing Date | 20060712 |
| Marketing Category Name | ANDA |
| Labeler Name | PharmaDerm a division of Fougera Pharmaceuticals Inc. |
| Substance Name | TERCONAZOLE |
| Strength Number | 80 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |