Application Sponsors
| ANDA 077520 | SUN PHARM INDUSTRIES | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 10MG | 0 | LOVASTATIN | LOVASTATIN |
| 002 | TABLET;ORAL | 20MG | 0 | LOVASTATIN | LOVASTATIN |
| 003 | TABLET;ORAL | 40MG | 0 | LOVASTATIN | LOVASTATIN |
FDA Submissions
| ORIG | 1 | AP | 2006-04-14 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2007-10-05 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-05-01 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-12-29 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2014-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2017-08-04 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 14 | Null | 15 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 77520
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)