Orange Book product · Generic (ANDA)
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE
At a glance
Jul 06, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 06, 2020
6 yr ago
Today
Pharmaceutical detail
Active ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213324
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CYCLOBENZAPRINE HYDROCHLORIDE
- 2025TONMYABrand (NDA)
NDA 219428 · TONIX
- 2007AMRIXBrand (NDA)
NDA 021777 · TEVA PHARMS INTL
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NDA 017821 · JANSSEN RES AND DEV
- 2024CYCLOBENZAPRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218936 · RISING
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ANDA 214732 · NOVAST LABS
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ANDA 207314 · MACLEODS PHARMS LTD
- 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.
