Application Sponsors
ANDA 214092 | SCIEGEN PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 10MG;100MG | 0 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA |
002 | TABLET;ORAL | 25MG;100MG | 0 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA |
003 | TABLET;ORAL | 25MG;250MG | 0 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-05-07 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 214092
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-05-07
)
)