Application Sponsors
| ANDA 078536 | SUN PHARM INDS | |
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
| ORIG | 1 | AP | 2008-10-28 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-10-04 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2013-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2015-02-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2018-07-10 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2021-02-09 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 23 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 78536
[companyName] => SUN PHARM INDS
[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":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)