Application Sponsors
| ANDA 081113 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 1MG | 0 | ERGOLOID MESYLATES | ERGOLOID MESYLATES |
FDA Submissions
| ORIG | 1 | AP | 1991-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-06-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-10-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-06-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-06-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-08-06 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-04-09 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 81113
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"ERGOLOID MESYLATES","activeIngredients":"ERGOLOID MESYLATES","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ERGOLOID MESYLATES","submission":"ERGOLOID MESYLATES","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)