Orange Book product · Brand (NDA)
ZEMURON
ROCURONIUM BROMIDE
At a glance
Mar 17, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 1994
32 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ROCURONIUM BROMIDE
Strength
100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020214
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025ROCURONIUM BROMIDEBrand (NDA)
NDA 219108 · B BRAUN MEDICAL
- 2025ROCURONIUM BROMIDEBrand (NDA)
NDA 217472 · FRESENIUS KABI USA
- 2026ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 220124 · ASPIRO
- 2026ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 213476 · KNACK
- 2025ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 219674 · MANKIND PHARMA
- 2024ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 217092 · STERISCIENCE
- 2024ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 204918 · RISING
- 2024ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 215684 · SHANDONG
- 2023ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 217034 · HIKMA
- 2023ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 213453 · MEITHEAL
- 2023ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 216234 · CAPLIN
- 2022ROCURONIUM BROMIDEGeneric (ANDA)
ANDA 212668 · PRINSTON INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
