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Gynazole-1
Gynazole-1 - 64011-001-08 - (butoconazole nitrate)
Drug Information of Gynazole-1
| Product NDC: | 64011-001 |
| Proprietary Name: | Gynazole-1 |
| Non Proprietary Name: | butoconazole nitrate |
| Active Ingredient(s): | 20 mg/g & nbsp; butoconazole nitrate |
| Administration Route(s): | VAGINAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Gynazole-1
| Product NDC: | 64011-001 |
| Labeler Name: | Ther-Rx Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA072838 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20091123 |
Package Information of Gynazole-1
| Package NDC: | 64011-001-08 |
| Package Description: | 5 g in 1 APPLICATOR (64011-001-08) |
NDC Information of Gynazole-1
| NDC Code | 64011-001-08 |
| Proprietary Name | Gynazole-1 |
| Package Description | 5 g in 1 APPLICATOR (64011-001-08) |
| Product NDC | 64011-001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | butoconazole nitrate |
| Dosage Form Name | CREAM |
| Route Name | VAGINAL |
| Start Marketing Date | 20091123 |
| Marketing Category Name | NDA |
| Labeler Name | Ther-Rx Corporation |
| Substance Name | BUTOCONAZOLE NITRATE |
| Strength Number | 20 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |
