Application Sponsors
ANDA 201191 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | 0 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-03-09 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-12-11 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2015-12-11 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201191
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/09\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/11\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-12-11
)
)