Documents
Application Sponsors
ANDA 213091 | DR REDDYS LABS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | CAPSULE;ORAL | 75MG | 0 | PALBOCICLIB | PALBOCICLIB |
002 | CAPSULE;ORAL | 100MG | 0 | PALBOCICLIB | PALBOCICLIB |
003 | CAPSULE;ORAL | 125MG | 0 | PALBOCICLIB | PALBOCICLIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-08-18 | STANDARD |
Submissions Property Types
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
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[ApplNo] => 213091
[companyName] => DR REDDYS LABS LTD
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[products] => [{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/18\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-08-18
)
)