Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
Application Products
| 001 | CAPSULE;ORAL | 250MG | 0 | LARODOPA | LEVODOPA |
| 002 | CAPSULE;ORAL | 100MG | 0 | LARODOPA | LEVODOPA |
| 003 | TABLET;ORAL | 250MG | 0 | LARODOPA | LEVODOPA |
| 004 | TABLET;ORAL | 500MG | 0 | LARODOPA | LEVODOPA |
| 005 | TABLET;ORAL | 100MG | 0 | LARODOPA | LEVODOPA |
| 006 | CAPSULE;ORAL | 500MG | 0 | LARODOPA | LEVODOPA |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1970-06-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1974-08-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1974-08-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1974-11-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1975-01-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1975-08-22 | PRIORITY |
| REMS; REMS | SUPPL | 28 | AP | 1977-12-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1977-01-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1978-03-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1977-04-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 1977-05-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1977-08-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1977-08-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1979-09-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1980-06-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1980-08-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1983-05-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1983-12-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 42 | AP | 1986-01-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1993-01-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1997-05-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1997-09-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1997-09-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1998-05-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1998-08-19 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 16912
[companyName] => ROCHE
[docInserts] => ["",""]
[products] => [{"drugName":"LARODOPA","activeIngredients":"LEVODOPA","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LARODOPA","activeIngredients":"LEVODOPA","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LARODOPA","activeIngredients":"LEVODOPA","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LARODOPA","activeIngredients":"LEVODOPA","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LARODOPA","activeIngredients":"LEVODOPA","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LARODOPA","activeIngredients":"LEVODOPA","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LARODOPA","submission":"LEVODOPA","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LARODOPA","submission":"LEVODOPA","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LARODOPA","submission":"LEVODOPA","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LARODOPA","submission":"LEVODOPA","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LARODOPA","submission":"LEVODOPA","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LARODOPA","submission":"LEVODOPA","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)