Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211798
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
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 |
---|---|---|---|---|---|---|---|
01/25/2019 | ORIG-1 | Approval | STANDARD |
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 | 076533 | APOTEX |
TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208187 | CADILA |
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 | 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 |
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 |