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FDA Purple Book product · 351(a) biologic

Viokace

pancrelipase

Viokace, BLA 022542, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 2 exact FDA presentation rows, and no exact reference-product relationship is asserted. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 022542 2 presentationsRxLicensed Viokace, LLC
Approved
Mar 01, 2012
License type
351(a)
Marketing
Rx
Listed patents
0
Viokace (pancrelipase) is Viokace, LLC's FDA-licensed 351(a) biologic under BLA 022542, approved in 2012. No 351(k) product in the loaded Purple Book family data explicitly references Viokace; that bounded result is not a claim about future reference-product eligibility.

Sourced from the FDA Purple Book · verified Jul 02, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

022542

Regulatory role

351(a) biologic

Applicant

Viokace, LLC

Applicant is not automatically the physical manufacturer.

Presentations

2

Exact FDA presentation rows under this BLA.

Approval

Mar 01, 2012

Reference product

Not stated

Viokace is an FDA-licensed 351(a) biologic.

No 351(k) product in the loaded Purple Book family data explicitly references Viokace.

Substitution boundary

The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.

Key dates

Licensure & exclusivity

  1. Approval

    Approval date of this BLA submission.

    Mar 01, 2012

    14 yr 7 mo ago

  2. Today

Strengths & presentations

2 FDA presentation rows · BLA 022542

Strength

10,440USP UNITS; 39,150USP UNITS; 39,150USP UNITS

Dosage form

Tablet

Route

Oral

Presentation

Not listed

Center

CDER

License number

2196

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
ProductStrengthDosage formRoutePresentationLicensureMarketing
00110,440USP UNITS; 39,150USP UNITS; 39,150USP UNITSTabletOralNot listedLicensedRx
00220,880USP UNITS; 78,300USP UNITS; 78,300USP UNITSTabletOralNot listedLicensedRx

Exact-source evidence coverage

Labeling & approval review

Current product label

Candidate awaiting exact-BLA match

FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.

Inspect FDA label candidate

FDA approval evidence

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables
View full family

The current record does not expose a reference-product name or an exact linked 351(k) family for Viokace.

No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.

Published patents

BPCIA patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Oral and Tablet; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Viokace, LLC is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Viokace is an FDA-licensed 351(a) biologic. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data
Source kind · Advanced Search
Checked Jul 02, 2026
FDA source FDA source
  • advanced-searchAdvanced Search · Jul 02, 2026

What this record does not establish

  • Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
  • The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
  • Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
  • A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
  • Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions
  • v2Jul 02, 2026

Viokace: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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