Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078868
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/03/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078868s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/25/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
02/23/2016 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
TIZANIDINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213223 | ALEMBIC |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212196 | ALKEM LABS LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078868 | APOTEX INC |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213544 | AUROBINDO PHARMA LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210021 | CADILA PHARMS LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209605 | JUBILANT GENERICS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210267 | NOVAST LABS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213798 | RUBICON |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208622 | ZYDUS PHARMS |
ZANAFLEX | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021447 | LEGACY PHARMA USA |
CAPSULE;ORAL; EQ 4MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213223 | ALEMBIC |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212196 | ALKEM LABS LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078868 | APOTEX INC |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213365 | APPCO |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213544 | AUROBINDO PHARMA LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210021 | CADILA PHARMS LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209605 | JUBILANT GENERICS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210267 | NOVAST LABS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213798 | RUBICON |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208622 | ZYDUS PHARMS |
ZANAFLEX | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021447 | LEGACY PHARMA USA |
CAPSULE;ORAL; EQ 6MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213223 | ALEMBIC |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212196 | ALKEM LABS LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078868 | APOTEX INC |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213365 | APPCO |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213544 | AUROBINDO PHARMA LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210021 | CADILA PHARMS LTD |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209605 | JUBILANT GENERICS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210267 | NOVAST LABS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213798 | RUBICON |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208622 | ZYDUS PHARMS |
ZANAFLEX | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021447 | LEGACY PHARMA USA |