| Product NDC: | 0378-7017 |
| Proprietary Name: | Bicalutamide |
| Non Proprietary Name: | bicalutamide |
| Active Ingredient(s): | 50 mg/1 & nbsp; bicalutamide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0378-7017 |
| Labeler Name: | Mylan Pharmaceuticals Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA079185 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120822 |
| Package NDC: | 0378-7017-93 |
| Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7017-93) |
| NDC Code | 0378-7017-93 |
| Proprietary Name | Bicalutamide |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7017-93) |
| Product NDC | 0378-7017 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | bicalutamide |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20120822 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc |
| Substance Name | BICALUTAMIDE |
| Strength Number | 50 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] |