Orange Book product · Brand (NDA)
AMRIX
CYCLOBENZAPRINE HYDROCHLORIDE
At a glance
Feb 01, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2007
19 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Strength
15MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021777
Product number
001
Marketing status
RX
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.
- 2025TONMYABrand (NDA)
NDA 219428 · TONIX
- —FLEXERILBrand (NDA)
NDA 017821 · JANSSEN RES AND DEV
- 2024CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218936 · RISING
- 2024CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214732 · NOVAST LABS
- 2024CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207314 · MACLEODS PHARMS LTD
- 2020CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213324 · UNICHEM
- 2018CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206703 · APOTEX
- 2017CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208170 · RUBICON RESEARCH
- 2015CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078218 · CHARTWELL RX
- 2013CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091281 · TWI PHARMS INC
- 2011CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078048 · KVK TECH
- 2010CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090478 · INVAGEN PHARMS
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.
