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FDA Purple Book product · 351(a) biologic

Aranesp

darbepoetin alpha

Aranesp, BLA 103951, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 49 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 103951 49 presentationsDiscLicensed Amgen Inc.
Approved
Jun 29, 2006
License type
351(a)
Marketing
Disc
Listed patents
0
Aranesp (darbepoetin alpha) is Amgen Inc.'s FDA-licensed 351(a) biologic under BLA 103951, approved in 2006. No 351(k) product in the loaded Purple Book family data explicitly references Aranesp; 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

103951

Regulatory role

351(a) biologic

Applicant

Amgen Inc.

Applicant is not automatically the physical manufacturer.

Presentations

49

Exact FDA presentation rows under this BLA.

Approval

Jun 29, 2006

Reference product

Not stated

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

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

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.

    Jun 29, 2006

    20 yr 4 mo ago

  2. Today

Strengths & presentations

49 FDA presentation rows · BLA 103951

Strength

25MCG/1ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

1080

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
00125MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedRx
00240MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedRx
00360MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedRx
004100MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedRx
005200MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedRx
00625MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
00740MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
00860MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
009100MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
010200MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
011150MCG/0.75MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
012300MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
013500MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
01460MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
015100MCG/0.5MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
016150MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
017200MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
018300MCG/0.6MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
019500MCG/1MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
02025MCG/0.42MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
02125MCG/0.42MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
02240MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedDisc
02340MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
02460MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
025100MCG/0.5MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
026150MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
027200MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
028300MCG/0.6MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
029500MCG/1MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx
030150MCG/0.75MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
031300MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
032500MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialLicensedDisc
03325MCG/0.42MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
03440MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
03560MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
036100MCG/0.5MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
037150MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
038200MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
039300MCG/0.6MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
040500MCG/1MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
04125MCG/0.42MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
04240MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
04360MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
044100MCG/0.5MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
045150MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
046200MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
047300MCG/0.6MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
048500MCG/1MLInjectionIntravenous, SubcutaneousAutoinjectorLicensedDisc
04910MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeLicensedRx

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 Aranesp.

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

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

Administration fields

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

Applicant boundary

Amgen Inc. 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

Aranesp 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
  • v4Jul 02, 2026
  • v3Jul 02, 2026
  • v2Jul 02, 2026

Aranesp: 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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