Application Sponsors
| ANDA 073654 | SUN PHARM INDUSTRIES | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 100MG | 0 | METOPROLOL TARTRATE | METOPROLOL TARTRATE |
| 002 | TABLET;ORAL | 25MG | 0 | METOPROLOL TARTRATE | METOPROLOL TARTRATE |
| 003 | TABLET;ORAL | 50MG | 0 | METOPROLOL TARTRATE | METOPROLOL TARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1993-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1999-03-22 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1999-10-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-03-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2003-01-06 | |
| LABELING; Labeling | SUPPL | 28 | AP | 2007-05-09 | |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-07-15 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2011-09-20 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2015-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2015-06-22 | STANDARD |
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 | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 34 | Null | 15 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 73654
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)