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FDA Purple Book · Reference family

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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1983

Reference approved

Reference product

351(a)BLA 018263

Microlite radiolabeled albumin technetium Tc-99m albumin colloid kit

Pharmalucence Inc

Approved
Mar 25, 1983
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for radiolabeled albumin technetium Tc-99m albumin colloid kit, in chronological order.

  1. Reference approval

    Approval date of the reference radiolabeled albumin technetium Tc-99m albumin colloid kit product.

    43 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for radiolabeled albumin technetium Tc-99m albumin colloid kit (Microlite)?

No 351(k) biosimilars or interchangeable biosimilars referencing radiolabeled albumin technetium Tc-99m albumin colloid kit are listed in the FDA Purple Book yet.

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