Application Sponsors
ANDA 073586 | IDT AUSTRALIA LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | 10MG;100MG | 0 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA |
FDA Submissions
| ORIG | 1 | AP | 1995-06-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-01-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-01-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-08-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-11-06 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
CDER Filings
IDT AUSTRALIA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 73586
[companyName] => IDT AUSTRALIA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)