TWINRIX - Hepatitis A and Hepatitis B (Recombinant) Vaccine
Navigation: NDC > Supplier starting with: G > GLAXOSMITHKLINE BIOLOGICALS SA| Field | Value |
|---|---|
| NDC Code: | 58160-815 |
| Proprietary Name: | TWINRIX |
| Suffix: | |
| Non-Proprietary Name: | Hepatitis A and Hepatitis B (Recombinant) Vaccine |
| Dosage Form: | INJECTION, SUSPENSION |
| Method: | INTRAMUSCULAR |
| Original Marketing Date: | 07-06-2007 |
| Category Name: | BLA |
| Application Number: | BLA103850 |
| Labeler: | GLAXOSMITHKLINE BIOLOGICALS SA |
| Substance Name: | HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN |
| Active Numerator Strength: | 720; 20 |
| Active Ingredient Unit: | [iU]/mL; ug/mL |
| Pharm Classes: | Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] |
| DEA Schedule: |