Application Sponsors
| ANDA 080655 | AUROLIFE PHARMA LLC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 400MG | 0 | MEPROBAMATE | MEPROBAMATE |
FDA Submissions
| ORIG | 1 | AP | 1972-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 71 | AP | 1982-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 1982-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1982-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1982-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 1983-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 1983-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 81 | AP | 1983-11-30 | |
| LABELING; Labeling | SUPPL | 84 | AP | 1988-03-28 | |
| LABELING; Labeling | SUPPL | 85 | AP | 1989-08-04 | |
| LABELING; Labeling | SUPPL | 86 | AP | 1989-10-18 | |
| LABELING; Labeling | SUPPL | 87 | AP | 1989-12-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 88 | AP | 1995-02-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 1997-05-05 | |
Submissions Property Types
| SUPPL | 42 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 71 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 0 |
| SUPPL | 80 | Null | 0 |
| SUPPL | 81 | Null | 0 |
| SUPPL | 88 | Null | 0 |
| SUPPL | 89 | Null | 0 |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 80655
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"MEPROBAMATE","activeIngredients":"MEPROBAMATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MEPROBAMATE","submission":"MEPROBAMATE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)