Question 1

What is Human Albumin Grifols in the FDA Purple Book?

Accepted Answer

Human Albumin Grifols, BLA 103352, is listed as a 351(a) biologic with 4 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 103352?

Accepted Answer

Human Albumin Grifols, BLA 103352, lists Instituto Grifols, S.A. 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 Human Albumin Grifols?

Accepted Answer

Human Albumin Grifols, BLA 103352, has 4 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 Human Albumin Grifols's reference-product relationship?

Accepted Answer

Human Albumin Grifols, BLA 103352, 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.

Question 5

Is Human Albumin Grifols interchangeable?

Accepted Answer

Human Albumin Grifols, BLA 103352, 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 Human Albumin Grifols licensed by FDA?

Accepted Answer

Human Albumin Grifols, BLA 103352, has a listed FDA approval date of Feb 17, 1995. 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 Human Albumin Grifols's FDA label?

Accepted Answer

Human Albumin Grifols, BLA 103352, 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 Human Albumin Grifols?

Accepted Answer

Human Albumin Grifols, BLA 103352, 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 Human Albumin Grifols?

Accepted Answer

Human Albumin Grifols, BLA 103352, 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	12.5G/50ML	Injection	Intravenous	Single-Dose Vial	Licensed	Disc
002	20G/100ML	Injection	Intravenous	Single-Dose Vial	Licensed	Rx
003	10G/50ML	Injection	Intravenous	Single-Dose Vial	Licensed	Disc
004	25G/100ML	Injection	Intravenous	Single-Dose Vial	Licensed	Disc

Human Albumin Grifols

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

Human Albumin Grifols: frequently asked questions

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