Application Sponsors
ANDA 090509 | DR REDDYS LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 0.5MG BASE | 0 | TACROLIMUS | TACROLIMUS |
002 | CAPSULE;ORAL | EQ 1MG BASE | 0 | TACROLIMUS | TACROLIMUS |
003 | CAPSULE;ORAL | EQ 5MG BASE | 0 | TACROLIMUS | TACROLIMUS |
FDA Submissions
| ORIG | 1 | AP | 2010-05-12 | |
LABELING; Labeling | SUPPL | 4 | AP | 2011-11-28 | |
LABELING; Labeling | SUPPL | 5 | AP | 2012-06-27 | |
LABELING; Labeling | SUPPL | 6 | AP | 2012-06-27 | |
LABELING; Labeling | SUPPL | 7 | AP | 2012-10-12 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2013-05-06 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2015-10-13 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2015-10-13 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2019-10-04 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2019-10-04 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2019-10-04 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2021-04-23 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2021-04-23 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 7 |
SUPPL | 11 | Null | 7 |
SUPPL | 16 | Null | 7 |
SUPPL | 17 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 22 | Null | 15 |
SUPPL | 23 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90509
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)