Application Sponsors
ANDA 091186 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | 0 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
FDA Submissions
| ORIG | 1 | AP | 2013-03-04 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-03-06 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2015-03-06 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2015-03-06 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2015-09-21 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2016-07-11 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2020-02-21 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 11 | Null | 7 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 91186
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)