Purple Book reference family · 351(a) biologic
radiolabeled albumin technetium Tc-99m albumin colloid kit (Microlite)
radiolabeled albumin technetium Tc-99m albumin colloid kit is an FDA-licensed reference biologic from Pharmalucence Inc.
351(a) biologicBLA 018263 Pharmalucence Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1983
Reference product
Originator biologic
351(a)BLA 018263
Microlite radiolabeled albumin technetium Tc-99m albumin colloid kit
Pharmalucence Inc
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference radiolabeled albumin technetium Tc-99m albumin colloid kit product.
44 yr ago
radiolabeled albumin technetium Tc-99m albumin colloid kit: 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 radiolabeled albumin technetium Tc-99m albumin colloid kit.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
