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 Label PDF Open on FDA Purple Book

Apr 02, 1996

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human)) is Kamada Ltd.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 1996. No biosimilars referencing Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized are listed in the Purple Book yet.

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

Key dates

Approval
Approval date of this BLA submission.
Apr 02, 1996
30 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 24, 2002
24 yr 8 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. No biosimilars or interchangeables reference it in the Purple Book yet.

17 additional BLA records for this product (other strengths or presentations) are in the same reference family.

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.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized are listed in the FDA Purple Book yet.

What is Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized's BLA number?

Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized is licensed under BLA 103649, held by Kamada Ltd..

When was Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized approved by the FDA?

Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized was approved by the FDA on Apr 02, 1996.

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