Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020397
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription AB Yes Yes
ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
11/27/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020397Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/07/2013 SUPPL-26 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
05/27/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/19/2013 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020397Orig1s023ltr.pdf
07/28/2006 SUPPL-21 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
05/17/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/10/2002 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/27/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20397slr014ltr.pdf
08/22/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/21/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/07/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/21/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/26/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/04/2000 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020397_S004_ZANAFLEX TABLETS_AP.pdf
10/23/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf
07/28/2006 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf

ZANAFLEX

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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