Orange Book product · Generic (ANDA)
TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE
At a glance
Nov 09, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2012
13 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TIZANIDINE HYDROCHLORIDE
Strength
EQ 2MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 091502
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TIZANIDINE HYDROCHLORIDE
- 2024ONTRALFYBrand (NDA)
NDA 216190 · FIDELITY BIOPHARMA
- 2002ZANAFLEXBrand (NDA)
NDA 021447 · LEGACY PHARMA USA
- 2000ZANAFLEXBrand (NDA)
NDA 020397 · LEGACY PHARMA USA
- 2024TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218920 · RISING
- 2024TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213365 · SENORES PHARMS
- 2020TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213798 · RUBICON RESEARCH
- 2020TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213544 · AUROBINDO PHARMA LTD
- 2020TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213223 · ALEMBIC
- 2019TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212196 · ALKEM LABS LTD
- 2019TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210021 · CADILA PHARMS LTD
- 2019TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210267 · INGENUS PHARMS LLC
- 2019TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211798 · ALKEM LABS LTD
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.

