| Product NDC: | 49281-880 |
| Proprietary Name: | THERACYS |
| Non Proprietary Name: | BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN |
| Active Ingredient(s): | 81 mg/1 & nbsp; BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN |
| Administration Route(s): | INTRAVESICAL |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 49281-880 |
| Labeler Name: | Sanofi Pasteur Inc. |
| Product Type: | VACCINE |
| FDA Application Number: | BLA103943 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20110722 |
| Package NDC: | 49281-880-03 |
| Package Description: | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 PACKAGE (49281-880-03) |
| NDC Code | 49281-880-03 |
| Proprietary Name | THERACYS |
| Package Description | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 PACKAGE (49281-880-03) |
| Product NDC | 49281-880 |
| Product Type Name | VACCINE |
| Non Proprietary Name | BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVESICAL |
| Start Marketing Date | 20110722 |
| Marketing Category Name | BLA |
| Labeler Name | Sanofi Pasteur Inc. |
| Substance Name | BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN |
| Strength Number | 81 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |