Documents
Application Sponsors
ANDA 201577 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | 250MG/VIAL | 0 | BIVALIRUDIN | BIVALIRUDIN |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2017-05-26 | |
LABELING; Labeling | SUPPL | 2 | AP | 2019-10-01 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201577
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"BIVALIRUDIN","activeIngredients":"BIVALIRUDIN","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201577Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-01
)
)