Purple Book product · Reference 351(a)

Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized

Rho(D) Immune Globulin Intravenous (Human)

351(a)BLA 103649DiscLicensed Kamada Ltd.

View Rho(D) Immune Globulin Intravenous (Human) family Open on FDA Purple Book

At a glance

Apr 02, 1996

Approved

Reference 351(a)

License type

Disc

Marketing

Patents listed

Key dates

Approval
Approval date of this BLA submission.
Apr 02, 1996
30 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 24, 2002
24 yr 7 mo ago
Today

Pharmaceutical detail

Strength

600IU

Dosage form

For Injection

Route

Intravenous

Presentation

Vial

Center

CBER

License number

2098

Product number

006

Submission type

Original

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.

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.

Taxonomy and ontology

12 terms

center

Center for Biologics Evaluation and Research

center · CBER

application pathway

Biologics License Application

blaNumber · BLA

license type

351(a)

blaType · 351(a)

application pathway

Section 351(a) Biologic

blaType · 351(a)

product role

Reference or Standalone Biologic

blaType · Reference product

marketing status

Discontinued

marketingStatus · Disc

licensure status

Licensed

licensure · Licensed

route

Intravenous

routeOfAdministration · Intravenous

dosage form

For Injection

dosageForm · For Injection

source kind

Monthly Download

sourceKind · monthly_download

Food and Drug Administrationparent ofCenter for Biologics Evaluation and Research
Food and Drug Administrationsource forMonthly Download
Biologics License Applicationparent ofSection 351(a) Biologic
Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
Section 351(a) Biologicmaps to351(a)
351(a)classifiesReference or Standalone Biologic

Source provenance

Source kind · Monthly download

Checked May 28, 2026

FDA release · April 2026

FDA source FDA source

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