Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078868
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
02/23/2016 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

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 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 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 091502 MYLAN PHARMS INC
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 207199 PAR PHARM INC
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 COVIS PHARMA BV

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 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 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 091502 MYLAN PHARMS INC
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 207199 PAR PHARM INC
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 COVIS PHARMA BV

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 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 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 091502 MYLAN PHARMS INC
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 207199 PAR PHARM INC
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 COVIS PHARMA BV

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