Product NDC: | 0052-0602 |
Proprietary Name: | TICE BCG |
Non Proprietary Name: | BACILLUS CALMETTE-GUERIN |
Active Ingredient(s): | 50 mg/50mL & nbsp; BACILLUS CALMETTE-GUERIN |
Administration Route(s): | INTRAVESICAL |
Dosage Form(s): | POWDER, FOR SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0052-0602 |
Labeler Name: | Organon Pharmaceuticals USA |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA102821 |
Marketing Category: | BLA |
Start Marketing Date: | 20091009 |
Package NDC: | 0052-0602-02 |
Package Description: | 1 VIAL in 1 BOX (0052-0602-02) > 50 mL in 1 VIAL |
NDC Code | 0052-0602-02 |
Proprietary Name | TICE BCG |
Package Description | 1 VIAL in 1 BOX (0052-0602-02) > 50 mL in 1 VIAL |
Product NDC | 0052-0602 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | BACILLUS CALMETTE-GUERIN |
Dosage Form Name | POWDER, FOR SUSPENSION |
Route Name | INTRAVESICAL |
Start Marketing Date | 20091009 |
Marketing Category Name | BLA |
Labeler Name | Organon Pharmaceuticals USA |
Substance Name | BACILLUS CALMETTE-GUERIN |
Strength Number | 50 |
Strength Unit | mg/50mL |
Pharmaceutical Classes | Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],BCG Vaccine [Chemical/Ingredient],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] |