Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076533
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription AB No No
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;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
01/16/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/28/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/02/2008 SUPPL-2 Labeling

Label is not available on this site.

TIZANIDINE HYDROCHLORIDE

TABLET;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 TABLET;ORAL Prescription No AB 211798 ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076284 ANI PHARMS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076533 APOTEX
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076280 CASI PHARMS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076286 DR REDDYS LABS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076347 EPIC PHARMA LLC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076354 MYLAN
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076281 OXFORD PHARMS
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 076416 SUN PHARM INDS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 091283 UNICHEM LABS LTD
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 208187 ZYDUS PHARMS

TABLET;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 TABLET;ORAL Prescription No AB 211798 ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076284 ANI PHARMS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076533 APOTEX
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076280 CASI PHARMS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076286 DR REDDYS LABS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076347 EPIC PHARMA LLC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076354 MYLAN
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076281 OXFORD PHARMS
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076416 SUN PHARM INDS INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 091283 UNICHEM LABS LTD
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 208187 ZYDUS PHARMS
ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription Yes AB 020397 COVIS PHARMA BV

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