Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021447
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 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 |
---|---|---|---|---|---|
12/18/2020 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021447s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021447Orig1s015ltr.pdf | |
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 |
---|---|---|---|---|---|
12/18/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021447s015lbl.pdf | |
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 | 213223 | ALEMBIC |
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 | 213544 | AUROBINDO PHARMA LTD |
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 | 210267 | NOVAST LABS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213798 | RUBICON |
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 | LEGACY PHARMA USA |
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 | 213223 | ALEMBIC |
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 | 213365 | APPCO |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213544 | AUROBINDO PHARMA LTD |
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 | 210267 | NOVAST LABS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213798 | RUBICON |
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 | LEGACY PHARMA USA |
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 | 213223 | ALEMBIC |
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 | 213365 | APPCO |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213544 | AUROBINDO PHARMA LTD |
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 | 210267 | NOVAST LABS |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213798 | RUBICON |
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 | LEGACY PHARMA USA |