BLA number
103914
FDA Purple Book product · 351(a) biologic
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Influenza Virus Vaccine
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent, BLA 103914, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 10 exact FDA presentation rows and states only source-supported reference relationships. It keeps the applicant separate from any unverified manufacturer and does not infer clinical labeling, substitution, availability, or patent conclusions.
351(a)BLA 103914 10 presentationsRxLicensed Sanofi Vaccines US Inc.
Approved
Dec 23, 2009
License type
351(a)
Marketing
Rx
Listed patents
0
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine) is Sanofi Vaccines US Inc.'s FDA-licensed 351(a) biologic under BLA 103914, approved in 2009. No 351(k) product in the loaded Purple Book family data explicitly references Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent; 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
Regulatory role
351(a) biologic
Applicant
Sanofi Vaccines US Inc.
Applicant is not automatically the physical manufacturer.
Presentations
10
Exact FDA presentation rows under this BLA.
Approval
Dec 23, 2009
Reference product
Not stated
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent is an FDA-licensed 351(a) biologic.
No 351(k) product in the loaded Purple Book family data explicitly references Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent.
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
Approval
Approval date of this BLA submission.
Dec 23, 2009
16 yr 10 mo ago
Today
Strengths & presentations
10 FDA presentation rows · BLA 103914
Strength
45UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Pre-Filled Syringe
Center
CBER
License number
1725
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Strength
45UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Single-Dose Vial
Center
CBER
License number
1725
Product number
002
Submission type
Original
Supplement number
0
Change type
Not listed
Strength
180 UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Pre-Filled Syringe
Center
CBER
License number
1725
Product number
003
Submission type
Supplement
Supplement number
5240
Change type
Not listed
Strength
27UG/0.1
Dosage form
Injection
Route
Intradermal
Presentation
Syringe
Center
CBER
License number
1725
Product number
004
Submission type
Supplement
Supplement number
5369
Change type
Not listed
Strength
60UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Pre-Filled Syringe
Center
CBER
License number
1725
Product number
005
Submission type
Supplement
Supplement number
5574
Change type
Not listed
Strength
60UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Single-Dose Vial
Center
CBER
License number
1725
Product number
006
Submission type
Supplement
Supplement number
5574
Change type
Not listed
Strength
60UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Multi-Dose Vial
Center
CBER
License number
1725
Product number
007
Submission type
Supplement
Supplement number
5574
Change type
Not listed
Strength
36UG/.5ML
Dosage form
Injection
Route
Intradermal
Presentation
Pre-Filled Syringe
Center
CBER
License number
1725
Product number
008
Submission type
Supplement
Supplement number
5733
Change type
Not listed
Strength
240UG/.7ML
Dosage form
Injection
Route
Intramuscular
Presentation
Pre-Filled Syringe
Center
CBER
License number
1725
Product number
009
Submission type
Supplement
Supplement number
6290
Change type
Not listed
Strength
45UG/.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Multi-Dose Vial
Center
CBER
License number
1725
Product number
010
Submission type
Supplement
Supplement number
6792
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.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Licensed | Rx |
| 002 | 45UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Licensed | Disc |
| 003 | 180 UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Licensed | Rx |
| 004 | 27UG/0.1 | Injection | Intradermal | Syringe | Licensed | Disc |
| 005 | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Licensed | Rx |
| 006 | 60UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Licensed | Disc |
| 007 | 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Licensed | Rx |
| 008 | 36UG/.5ML | Injection | Intradermal | Pre-Filled Syringe | Licensed | Disc |
| 009 | 240UG/.7ML | Injection | Intramuscular | Pre-Filled Syringe | Licensed | Rx |
| 010 | 45UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Licensed | Rx |
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 candidateFDA 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
The current record does not expose a reference-product name or an exact linked 351(k) family for Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent.
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
10 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Intramuscular and Intradermal and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
Sanofi Vaccines US 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
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent 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- 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
- v6Jul 02, 2026
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent: 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
