Documents
Application Sponsors
ANDA 202357 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 80MG BASE | 0 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM |
FDA Submissions
| ORIG | 1 | AP | 2012-07-17 | |
LABELING; Labeling | SUPPL | 2 | AP | 2012-12-29 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2014-11-04 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2015-10-06 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2019-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2019-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2019-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2019-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2021-05-04 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2021-05-04 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2021-05-04 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2021-05-04 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 15 |
SUPPL | 11 | Null | 15 |
SUPPL | 13 | Null | 31 |
SUPPL | 14 | Null | 15 |
SUPPL | 15 | Null | 7 |
SUPPL | 16 | Null | 7 |
SUPPL | 17 | Null | 7 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202357
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202357Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/22\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/06\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/29\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-22
)
)