Orange Book product · Brand (NDA)
FLEXERIL
CYCLOBENZAPRINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 017821
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.
- 2025TONMYABrand (NDA)
NDA 219428 · TONIX
- 2007AMRIXBrand (NDA)
NDA 021777 · TEVA PHARMS INTL
- 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.
