| Product NDC: | 11399-005 |
| Proprietary Name: | Fareston |
| Non Proprietary Name: | toremifene citrate |
| Active Ingredient(s): | 60 mg/1 & nbsp; toremifene citrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 11399-005 |
| Labeler Name: | GTx, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020497 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19970630 |
| Package NDC: | 11399-005-01 |
| Package Description: | 100 TABLET in 1 BOTTLE (11399-005-01) |
| NDC Code | 11399-005-01 |
| Proprietary Name | Fareston |
| Package Description | 100 TABLET in 1 BOTTLE (11399-005-01) |
| Product NDC | 11399-005 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | toremifene citrate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 19970630 |
| Marketing Category Name | NDA |
| Labeler Name | GTx, Inc. |
| Substance Name | TOREMIFENE CITRATE |
| Strength Number | 60 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] |