Documents
Application Sponsors
ANDA 202194 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | 0 | LANSOPRAZOLE | LANSOPRAZOLE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2012-05-18 | |
LABELING; Labeling | SUPPL | 2 | AP | 2013-07-18 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-10-07 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-10-07 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2020-10-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2022-04-12 | UNKNOWN |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 8 | Null | 15 |
SUPPL | 11 | Null | 7 |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202194
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202194s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202194Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/18\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2013-07-18
)
)