ENGERIX-B is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen.
Product ID | 58160-821_15267df3-c997-4e6a-95bd-049846838c23 |
NDC | 58160-821 |
Product Type | Vaccine |
Proprietary Name | ENGERIX-B |
Generic Name | Hepatitis B Vaccine (recombinant) |
Dosage Form | Injection, Suspension |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 2007-03-28 |
Marketing Category | BLA / BLA |
Application Number | BLA103239 |
Labeler Name | GlaxoSmithKline Biologicals SA |
Substance Name | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN |
Active Ingredient Strength | 20 ug/mL |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2007-03-28 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2009-11-16 |
Marketing End Date | 2013-07-31 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2012-03-09 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Marketing Start Date | 2010-08-03 |
Marketing End Date | 2013-07-31 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2007-03-28 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2010-08-03 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2011-01-06 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Marketing Start Date | 2007-03-28 |
Marketing End Date | 2013-07-31 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Marketing Start Date | 2007-03-28 |
Marketing End Date | 2013-07-31 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Marketing Start Date | 2012-03-09 |
Marketing Category | BLA |
Application Number | BLA103239 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2007-03-28 |
Ingredient | Strength |
---|---|
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/mL |
NDC | Brand Name | Generic Name |
---|---|---|
50090-1223 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
50090-1706 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
58160-820 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
58160-821 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
68258-3042 | ENGERIX-B | ENGERIX-B |
0006-4093 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
0006-4094 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
0006-4981 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
0006-4992 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
0006-4995 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
50090-1716 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
50090-1719 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
50090-1849 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENGERIX-B 76050783 2832321 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 2000-05-17 |
ENGERIX-B 76050489 2451009 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 2000-05-17 |
ENGERIX-B 75022211 2019144 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A 1995-11-16 |