Orange Book product · Brand (NDA)

ROCURONIUM BROMIDE

Brand (NDA)NDA 219108RX B BRAUN MEDICAL

Oct 24, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 24, 2025
8 mo ago
Today
Patent 11998605 expires
Listed drug product patent expiration.
Jul 22, 2039
in 13 yr 3 mo

Active ingredient

ROCURONIUM BROMIDE

Strength

50MG/5ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 219108

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11998605	Jul 22, 2039	in 13 yr 3 mo	Product