Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
Application Products
001 | TABLET;ORAL | 12.5MG;200MG;50MG | 0 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA |
002 | TABLET;ORAL | 18.75MG;200MG;75MG | 0 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA |
003 | TABLET;ORAL | 25MG;200MG;100MG | 0 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA |
004 | TABLET;ORAL | 31.25MG;200MG;125MG | 0 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA |
005 | TABLET;ORAL | 37.5MG;200MG;150MG | 0 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA |
006 | TABLET;ORAL | 50MG;200MG;200MG | 0 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-08-13 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
CDER Filings
MYLAN
cder:Array
(
[0] => Array
(
[ApplNo] => 203424
[companyName] => MYLAN
[docInserts] => ["",""]
[products] => [{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"12.5MG;200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"18.75MG;200MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"25MG;200MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"31.25MG;200MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"37.5MG;200MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"50MG;200MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-08-13
)
)