Purple Book reference family · 351(a) biologic
albumin chromated CR-51 serum (Chromalbin)
albumin chromated CR-51 serum is an FDA-licensed reference biologic from Iso-Tex Diagnostics, Inc..
351(a) biologicBLA 017835 Iso-Tex Diagnostics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1976
Reference product
Originator biologic
351(a)BLA 017835
Chromalbin albumin chromated CR-51 serum
Iso-Tex Diagnostics, 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 albumin chromated CR-51 serum product.
51 yr 2 mo ago
albumin chromated CR-51 serum: 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 albumin chromated CR-51 serum.
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