Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 2MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
002 | CAPSULE;ORAL | EQ 4MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
003 | CAPSULE;ORAL | EQ 6MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2012-02-03 | |
LABELING; Labeling | SUPPL | 4 | AP | 2022-05-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 78868
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 6MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)