Application Sponsors
ANDA 090161 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | 0 | DIVALPROEX SODIUM | DIVALPROEX SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2012-03-15 | |
LABELING; Labeling | SUPPL | 3 | AP | 2014-11-22 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2014-11-22 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2016-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2020-02-21 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 10 | Null | 15 |
SUPPL | 11 | Null | 15 |
SUPPL | 14 | Null | 7 |
SUPPL | 15 | Null | 15 |
SUPPL | 16 | Null | 15 |
SUPPL | 17 | Null | 15 |
SUPPL | 18 | Null | 7 |
SUPPL | 19 | Null | 7 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90161
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)