| Product NDC: | 42291-228 |
| Proprietary Name: | Danazol |
| Non Proprietary Name: | Danazol |
| Active Ingredient(s): | 200 mg/1 & nbsp; Danazol |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 42291-228 |
| Labeler Name: | AvKARE, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077246 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120703 |
| Package NDC: | 42291-228-90 |
| Package Description: | 90 CAPSULE in 1 BOTTLE (42291-228-90) |
| NDC Code | 42291-228-90 |
| Proprietary Name | Danazol |
| Package Description | 90 CAPSULE in 1 BOTTLE (42291-228-90) |
| Product NDC | 42291-228 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Danazol |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120703 |
| Marketing Category Name | ANDA |
| Labeler Name | AvKARE, Inc. |
| Substance Name | DANAZOL |
| Strength Number | 200 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] |