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FDA Purple Book product · 351(a) biologic

Flebogamma 5%, Flebogamma 5% Dif

Immune Globulin Intravenous (Human)

Flebogamma 5%, Flebogamma 5% Dif, BLA 125077, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 8 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 125077 8 presentationsDiscLicensed Instituto Grifols, S.A.
Approved
Dec 15, 2003
License type
351(a)
Marketing
Disc
Listed patents
0
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human)) is Instituto Grifols, S.A.'s FDA-licensed 351(a) biologic under BLA 125077, approved in 2003. No 351(k) product in the loaded Purple Book family data explicitly references Flebogamma 5%, Flebogamma 5% Dif; 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

125077

Regulatory role

351(a) biologic

Applicant

Instituto Grifols, S.A.

Applicant is not automatically the physical manufacturer.

Presentations

8

Exact FDA presentation rows under this BLA.

Approval

Dec 15, 2003

Reference product

Not stated

Flebogamma 5%, Flebogamma 5% Dif is an FDA-licensed 351(a) biologic.

No 351(k) product in the loaded Purple Book family data explicitly references Flebogamma 5%, Flebogamma 5% Dif.

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.

    Dec 15, 2003

    22 yr 11 mo ago

  2. Today

Strengths & presentations

8 FDA presentation rows · BLA 125077

Strength

0.5G/10ML

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1181

Product number

001

Submission type

Original

Supplement number

0

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
0010.5G/10MLInjectionIntravenousSingle-Dose VialLicensedDisc
0022.5G/50MLInjectionIntravenousSingle-Dose VialLicensedDisc
0035G/100MLInjectionIntravenousSingle-Dose VialLicensedRx
00410G/200MLInjectionIntravenousSingle-Dose VialLicensedRx
00520G/400MLInjectionIntravenousSingle-Dose VialLicensedRx
0065G/50MLInjectionIntravenousSingle-Dose VialLicensedDisc
00710G/100MLInjectionIntravenousSingle-Dose VialLicensedDisc
00820G/200MLInjectionIntravenousSingle-Dose VialLicensedDisc

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 Flebogamma 5%, Flebogamma 5% Dif.

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

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

Administration fields

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

Applicant boundary

Instituto Grifols, S.A. 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

Flebogamma 5%, Flebogamma 5% Dif 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
  • 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
  • v5Jul 02, 2026
  • v4Jul 02, 2026
  • v3Jul 02, 2026
  • v2Jul 02, 2026

Flebogamma 5%, Flebogamma 5% Dif: 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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