Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020397
Company: LEGACY PHARMA USA
Company: LEGACY PHARMA USA
| 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ZANAFLEX | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 | 076533 | APOTEX |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208187 | CADILA |
| 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 | 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 |
| ZANAFLEX | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020397 | LEGACY PHARMA USA |