NDC 33332-018
AFLURIA
Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated)
AFLURIA is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus Pty Ltd. The primary component is Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated); Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated); Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated).
| Product ID | 33332-018_c5baabbc-73bd-4d58-9ced-d6611b9d884f |
| NDC | 33332-018 |
| Product Type | Vaccine |
| Proprietary Name | AFLURIA |
| Generic Name | Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2011-07-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125254 |
| Labeler Name | Seqirus Pty Ltd |
| Substance Name | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 33332-018-01
10 SYRINGE, GLASS in 1 CARTON (33332-018-01) > .5 mL in 1 SYRINGE, GLASS (33332-018-02)
| Marketing Start Date | 2011-07-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 33332-018-01 [33332001801]
AFLURIA INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125254 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2011-07-15 |
| Marketing End Date | 2019-11-01 |
NDC 33332-018-02 [33332001802]
AFLURIA INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125254 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2011-07-15 |
| Marketing End Date | 2019-11-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
NDC Crossover Matching brand name "AFLURIA" or generic name "Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 33332-015 | AFLURIA | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-018 | AFLURIA | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-115 | AFLURIA | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-118 | AFLURIA | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
Trademark Results [AFLURIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFLURIA 79004750 3057916 Live/Registered |
CSL Limited 2004-07-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.