Purple Book reference family · 351(a) biologic
kit for the preparation of technetium Tc-99m albumin aggregated (Draximage MAA)
kit for the preparation of technetium Tc-99m albumin aggregated is an FDA-licensed reference biologic from Jubilant DraxImage Inc..
351(a) biologicBLA 017881 Jubilant DraxImage Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1987
Reference product
Originator biologic
351(a)BLA 017881
Draximage MAA kit for the preparation of technetium Tc-99m albumin aggregated
Jubilant DraxImage Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference kit for the preparation of technetium Tc-99m albumin aggregated product.
39 yr 2 mo ago
kit for the preparation of technetium Tc-99m albumin aggregated: 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 kit for the preparation of technetium Tc-99m albumin aggregated.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

