Application Sponsors
ANDA 203261 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 25MG | 0 | CARBIDOPA | CARBIDOPA |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2014-03-10 | |
LABELING; Labeling | SUPPL | 5 | AP | 2020-04-19 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203261
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CARBIDOPA","activeIngredients":"CARBIDOPA","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/19\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-19
)
)