Product NDC: | 68382-224 |
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: | 68382-224 |
Labeler Name: | Zydus Pharmaceuticals (USA) Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA079089 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090706 |
Package NDC: | 68382-224-05 |
Package Description: | 500 TABLET, FILM COATED in 1 BOTTLE (68382-224-05) |
NDC Code | 68382-224-05 |
Proprietary Name | Bicalutamide |
Package Description | 500 TABLET, FILM COATED in 1 BOTTLE (68382-224-05) |
Product NDC | 68382-224 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Bicalutamide |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20090706 |
Marketing Category Name | ANDA |
Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
Substance Name | BICALUTAMIDE |
Strength Number | 50 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] |