Purple Book reference family · 351(a) biologic
Smallpox (Vaccinia) Vaccine, Live (Acam2000)
Smallpox (Vaccinia) Vaccine, Live is an FDA-licensed reference biologic from Emergent Product Development Gaithersburg, Inc..
351(a) biologicBLA 125158 Emergent Product Development Gaithersburg, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2007
Reference product
Originator biologic
351(a)BLA 125158
Acam2000 Smallpox (Vaccinia) Vaccine, Live
Emergent Product Development Gaithersburg, 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 Smallpox (Vaccinia) Vaccine, Live product.
19 yr 2 mo ago
Smallpox (Vaccinia) Vaccine, Live: 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 Smallpox (Vaccinia) Vaccine, Live.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
