Orange Book product · Brand (NDA)
TRACRIUM PRESERVATIVE FREE
ATRACURIUM BESYLATE
At a glance
Nov 23, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 23, 1983
43 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ATRACURIUM BESYLATE
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018831
Product number
001
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.
- 2017ATRACURIUM BESYLATEGeneric (ANDA)
ANDA 206096 · PHARMOBEDIENT
- 2017ATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 206001 · PHARMOBEDIENT
- 2015ATRACURIUM BESYLATEGeneric (ANDA)
ANDA 206011 · EUGIA PHARMA
- 2015ATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 206010 · EUGIA PHARMA
- 2012ATRACURIUM BESYLATEGeneric (ANDA)
ANDA 090761 · HOSPIRA INC
- 2012ATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 090782 · HOSPIRA INC
- 2012ATRACURIUM BESYLATEGeneric (ANDA)
ANDA 091489 · MEITHEAL
- 2012ATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 091488 · MEITHEAL
- 1998ATRACURIUM BESYLATEGeneric (ANDA)
ANDA 074945 · WATSON PHARMS TEVA
- 1998ATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 074944 · WATSON LABS INC
- 1997ATRACURIUM BESYLATEGeneric (ANDA)
ANDA 074824 · BAXTER HLTHCARE
- 1997ATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 074825 · BAXTER HLTHCARE
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.
