Documents
Application Sponsors
ANDA 205182 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | SOLUTION; INJECTION | 24MG/2.1ML | 0 | PLERIXAFOR | PLERIXAFOR |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-08-10 | STANDARD |
Submissions Property Types
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205182
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PLERIXAFOR","activeIngredients":"PLERIXAFOR","strength":"24MG\/2.1ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/10\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205182Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-08-10
)
)