Orange Book product · Brand (NDA)
ZANAFLEX
TIZANIDINE HYDROCHLORIDE
At a glance
Aug 29, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2002
24 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TIZANIDINE HYDROCHLORIDE
Strength
EQ 2MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021447
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.
- 2024ONTRALFYBrand (NDA)
NDA 216190 · FIDELITY BIOPHARMA
- 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
- 2018TIZANIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208187 · CADILA
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.
