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FLUZONE
FLUZONE - 49281-013-50 - (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED))
Drug Information of FLUZONE
| Product NDC: | 49281-013 |
| Proprietary Name: | FLUZONE |
| Non Proprietary Name: | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Active Ingredient(s): | 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL & nbsp; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of FLUZONE
| Product NDC: | 49281-013 |
| Labeler Name: | Sanofi Pasteur Inc. |
| Product Type: | VACCINE |
| FDA Application Number: | BLA103914 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20130628 |
Package Information of FLUZONE
| Package NDC: | 49281-013-50 |
| Package Description: | 10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50) > .5 mL in 1 SYRINGE, GLASS (49281-013-88) |
NDC Information of FLUZONE
| NDC Code | 49281-013-50 |
| Proprietary Name | FLUZONE |
| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50) > .5 mL in 1 SYRINGE, GLASS (49281-013-88) |
| Product NDC | 49281-013 |
| Product Type Name | VACCINE |
| Non Proprietary Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Dosage Form Name | INJECTION, SUSPENSION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20130628 |
| Marketing Category Name | BLA |
| Labeler Name | Sanofi Pasteur Inc. |
| Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Strength Number | 15; 15; 15 |
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
| Pharmaceutical Classes |
