Question 1

What is Humulin 70/30 in the FDA Purple Book?

Accepted Answer

Humulin 70/30, BLA 019717, is listed as a 351(a) biologic with 3 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.

Question 2

Who is responsible for BLA 019717?

Accepted Answer

Humulin 70/30, BLA 019717, lists Eli Lilly and Company 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.

Question 3

What presentations are listed for Humulin 70/30?

Accepted Answer

Humulin 70/30, BLA 019717, has 3 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.

Question 4

What is Humulin 70/30's reference-product relationship?

Accepted Answer

Humulin 70/30, BLA 019717, 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.

Question 5

Is Humulin 70/30 interchangeable?

Accepted Answer

Humulin 70/30, BLA 019717, 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.

Question 6

When was Humulin 70/30 licensed by FDA?

Accepted Answer

Humulin 70/30, BLA 019717, has a listed FDA approval date of Nov 07, 2013. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Question 7

Does this page summarize Humulin 70/30's FDA label?

Accepted Answer

Humulin 70/30, BLA 019717, 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.

Question 8

What patent information is published for Humulin 70/30?

Accepted Answer

Humulin 70/30, BLA 019717, 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.

Question 9

What exclusivity information is listed for Humulin 70/30?

Accepted Answer

Humulin 70/30, BLA 019717, 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.

Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML)	Injectable Suspension	Subcutaneous	Multi-Dose Vial	Licensed	OTC
002	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Injectable Suspension	Subcutaneous	Multi-Dose Vial	Licensed	OTC
003	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Injectable Suspension	Subcutaneous	Autoinjector	Licensed	OTC

Humulin 70/30

What this Purple Book record establishes

Key dates

Strengths & presentations

Exact presentation matrix

Exact-source evidence coverage

Reference product family

Published patents

Practical characteristics and limits

Presentation coverage

Administration fields

Applicant boundary

Regulatory comparison

Source provenance

What this record does not establish

Change history

Humulin 70/30: frequently asked questions

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