Application Sponsors
| ANDA 076286 | DR REDDYS LABS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 2MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 4MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2002-07-03 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2003-08-13 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2007-01-31 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2007-02-07 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2015-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-10-22 | STANDARD |
Submissions Property Types
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 15 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
DR REDDYS LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 76286
[companyName] => DR REDDYS LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)