Purple Book reference family · 351(a) biologic
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is an FDA-licensed reference biologic from Teva Women's Health, Inc..
351(a) biologicBLA 125296 Teva Women's Health, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011
Reference product
Originator biologic
351(a)BLA 125296
Not listed Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
Teva Women's Health, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Adenovirus Type 4 and Type 7 Vaccine, Live, Oral product.
15 yr 7 mo ago
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Adenovirus Type 4 and Type 7 Vaccine, Live, Oral.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

