Documents
Application Sponsors
ANDA 078997 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 150MG BASE | 0 | IBANDRONATE SODIUM | IBANDRONATE SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2012-04-30 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-07-15 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2015-07-15 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2020-06-19 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 15 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 78997
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBANDRONATE SODIUM","submission":"IBANDRONATE SODIUM","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)