| Product NDC: | 0069-0135 | 
| Proprietary Name: | BOSULIF | 
| Non Proprietary Name: | Bosutinib monohydrate | 
| Active Ingredient(s): | 100 mg/1 & nbsp; Bosutinib monohydrate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0069-0135 | 
| Labeler Name: | Pfizer Laboratories Div Pfizer Inc | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA203341 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20120904 | 
| Package NDC: | 0069-0135-01 | 
| Package Description: | 120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01) | 
| NDC Code | 0069-0135-01 | 
| Proprietary Name | BOSULIF | 
| Package Description | 120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01) | 
| Product NDC | 0069-0135 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Bosutinib monohydrate | 
| Dosage Form Name | TABLET, FILM COATED | 
| Route Name | ORAL | 
| Start Marketing Date | 20120904 | 
| Marketing Category Name | NDA | 
| Labeler Name | Pfizer Laboratories Div Pfizer Inc | 
| Substance Name | BOSUTINIB MONOHYDRATE | 
| Strength Number | 100 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |