What is Intron A in the FDA Purple Book?

Intron A, BLA 103132, is listed as a 351(a) biologic with 14 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 103132?

Intron A, BLA 103132, lists Merck Sharp & Dohme LLC as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Intron A?

Intron A, BLA 103132, has 14 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Intron A's reference-product relationship?

Intron A, BLA 103132, does not state a reference product in the loaded FDA row. That bounded result is not proof about future eligibility or relationships outside this snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Intron A interchangeable?

Intron A, BLA 103132, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Intron A licensed by FDA?

Intron A, BLA 103132, does not have an approval or first-licensure date in the loaded Purple Book row. The page keeps that field explicitly unavailable instead of estimating it from another product or source.

Does this page summarize Intron A's FDA label?

Intron A, BLA 103132, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Intron A?

Intron A, BLA 103132, has no published patent rows in the loaded Purple Book patent data. That is a bounded source result, not proof that no relevant patent rights exist or a freedom-to-operate conclusion.

What exclusivity information is listed for Intron A?

Intron A, BLA 103132, has 1 populated Purple Book exclusivity field, with the latest listed date on Nov 21, 2095. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Intron A

interferon alfa-2b

Intron A, BLA 103132, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 14 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 103132 14 presentationsDiscVoluntarily Revoked Merck Sharp & Dohme LLC

Approved

Not listed

License type

351(a)

Marketing

Disc

Listed patents

Intron A (interferon alfa-2b) is Merck Sharp & Dohme LLC's FDA-licensed 351(a) biologic under BLA 103132. No 351(k) product in the loaded Purple Book family data explicitly references Intron A; that bounded result is not a claim about future reference-product eligibility.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

103132

Regulatory role

351(a) biologic

Applicant

Merck Sharp & Dohme LLC

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Not listed

Reference product

Not stated

Intron A is an FDA-licensed 351(a) biologic.

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

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

Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 21, 2095
in 70 yr 2 mo

Strengths & presentations

14 FDA presentation rows · BLA 103132

Strength

3MIU

Dosage form

For Injection

Route

Intramuscular, Intravenous, Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

0002

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
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	3MIU	For Injection	Intramuscular, Intravenous, Subcutaneous	Single-Dose Vial	Voluntarily Revoked	Disc
002	5MIU	For Injection	Intramuscular, Intravenous, Subcutaneous	Single-Dose Vial	Voluntarily Revoked	Disc
003	10MIU	For Injection	Subcutaneous, Intravenous, Intralesional, Intramuscular	Single-Dose Vial	Voluntarily Revoked	Disc
004	25MIU	For Injection	Intramuscular, Intravenous, Subcutaneous	Multi-Dose Vial	Voluntarily Revoked	Disc
005	18MIU	For Injection	Intramuscular, Intravenous, Subcutaneous	Multi-Dose Vial	Voluntarily Revoked	Disc
006	50MIU	For Injection	Intramuscular, Intravenous, Subcutaneous	Single-Dose Vial	Voluntarily Revoked	Disc
007	3MIU	Injection	Subcutaneous, Intramuscular	Single-Dose Vial	Voluntarily Revoked	Disc
008	5MIU	Injection	Intralesional, Intramuscular, Subcutaneous	Single-Dose Vial	Voluntarily Revoked	Disc
009	10MIU	Injection	Intralesional, Intramuscular, Subcutaneous	Single-Dose Vial	Voluntarily Revoked	Disc
010	18MIU	Injection	Subcutaneous, Intramuscular	Multi-Dose Vial	Voluntarily Revoked	Disc
011	25MIU	Injection	Intralesional, Intramuscular, Subcutaneous	Multi-Dose Vial	Voluntarily Revoked	Disc
012	3MIU	Injection	Subcutaneous	Pre-Filled Syringe	Voluntarily Revoked	Disc
013	5MIU	Injection	Subcutaneous	Pre-Filled Syringe	Voluntarily Revoked	Disc
014	10MIU	Injection	Subcutaneous	Pre-Filled Syringe	Voluntarily Revoked	Disc

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

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 Intron A.

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

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

Administration fields

The loaded rows list Intramuscular, Intravenous, Subcutaneous, Subcutaneous, Intravenous, Intralesional, Intramuscular, Subcutaneous, Intramuscular, Intralesional, Intramuscular, Subcutaneous, and Subcutaneous and For Injection and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Merck Sharp & Dohme 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

Intron A 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 · Monthly download

Checked Aug 11, 2026

FDA release · June 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · 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

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Intron A: 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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