Application Sponsors
ANDA 214397 | MACLEODS PHARMS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | UNKNOWN | UNKNOWN | 0 | DOLUTEGRAVIR SODIUM | DOLUTEGRAVIR SODIUM |
002 | TABLET;ORAL | EQ 25MG BASE | 0 | DOLUTEGRAVIR SODIUM | DOLUTEGRAVIR SODIUM |
003 | TABLET;ORAL | EQ 50MG BASE | 0 | DOLUTEGRAVIR SODIUM | DOLUTEGRAVIR SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-03-22 | STANDARD |
Submissions Property Types
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 214397
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-03-22
)
)