What is Novolog in the FDA Purple Book?

Novolog, BLA 020986, is listed as a 351(a) reference biologic with 5 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 020986?

Novolog, BLA 020986, lists Novo Nordisk Inc. 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 Novolog?

Novolog, BLA 020986, has 5 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 Novolog's reference-product relationship?

Novolog, BLA 020986, is supported as a reference biologic by exact-BLA evidence and has 2 name-linked 351(k) follow-on products in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Novolog interchangeable?

Novolog, BLA 020986, 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 Novolog licensed by FDA?

Novolog, BLA 020986, has a listed FDA approval date of Jun 07, 2000. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Novolog's FDA label?

Novolog, BLA 020986, 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. 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 Novolog?

Novolog, BLA 020986, 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 Novolog?

Novolog, BLA 020986, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · 351(a) biologic

Novolog

insulin aspart

Novolog, BLA 020986, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 5 exact FDA presentation rows, and 2 FDA rows name-link 351(k) follow-on products to its reference family. 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 020986 5 presentationsRxLicensed Novo Nordisk Inc.

Approved

Jun 07, 2000

License type

351(a)

Marketing

Listed patents

Novolog (insulin aspart) is Novo Nordisk Inc.'s FDA-licensed 351(a) biologic under BLA 020986, approved in 2000. 2 distinct approved follow-on biologics explicitly reference Novolog (Merilog and Kirsty), making its reference-product role visible in the loaded family data.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

020986

Regulatory role

351(a) reference biologic

Applicant

Novo Nordisk Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Jun 07, 2000

Follow-on biologics

Novolog is a 351(a) reference biologic supported by exact-BLA evidence.

2 distinct licensed follow-on biologics in the loaded Purple Book data name Novolog as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Jun 07, 2000
26 yr 8 mo ago
Today

Strengths & presentations

5 FDA presentation rows · BLA 020986

Strength

1,000UNITS/10ML (100UNITS/ML)

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

1261

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	1,000UNITS/10ML (100UNITS/ML)	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Licensed	Rx
002	300UNITS/3ML (100UNITS/ML)	Injection	Subcutaneous	Multi-Dose Cartridge	Licensed	Rx
003	300UNITS/3ML (100UNITS/ML)	Injection	Subcutaneous	Autoinjector	Licensed	Rx
004	300UNITS/3ML (100UNITS/ML)	Injection	Subcutaneous	Autoinjector	Licensed	Disc
005	300UNITS/3ML (100UNITS/ML)	Injection	Subcutaneous	Autoinjector	Licensed	Disc

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

2 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Novolog; 1 is designated interchangeable and 2 have a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Novologinsulin aspart	351(a) reference biologic	020986	Jun 07, 2000	300UNITS/3ML (100UNITS/ML) · Subcutaneous	Rx
Meriloginsulin aspart-szjj	351(k) biosimilar	761325	Feb 14, 2025	1,000UNITS/10ML (100UNITS/ML) · Subcutaneous	Rx
Kirstyinsulin aspart-xjhz	351(k) interchangeable biosimilar	761188	Jul 15, 2025	300UNITS/3ML (100UNITS/ML) · Subcutaneous	Rx

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

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

Administration fields

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

Applicant boundary

Novo Nordisk 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

Novolog is a 351(a) reference biologic supported by exact-BLA evidence. 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

Novolog: 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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