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] |