Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021447
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription AB Yes No
ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE;ORAL Prescription AB Yes No
ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21447lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21447ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-447_Zanaflex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s011,020397Orig1s026ltr.pdf
03/08/2013 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s005ltr.pdf
07/28/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021, 021447s002LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf
07/28/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf
08/29/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21447lbl.pdf

ZANAFLEX

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 207199 PAR PHARM INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 210267 RICONPHARMA LLC
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 207199 PAR PHARM INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE;ORAL Prescription No AB 210267 RICONPHARMA LLC
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 207199 PAR PHARM INC
TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE;ORAL Prescription No AB 210267 RICONPHARMA LLC
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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