Application Sponsors
| ANDA 089346 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 350MG | 0 | CARISOPRODOL | CARISOPRODOL |
FDA Submissions
| ORIG | 1 | AP | 1991-10-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-06-22 | |
| 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 | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1999-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-11-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-11-06 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2001-11-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-09-27 | |
| LABELING; Labeling | SUPPL | 18 | AP | 2002-09-27 | |
| LABELING; Labeling | SUPPL | 30 | AP | 2007-01-25 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2009-03-20 | |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-03-09 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2013-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2014-01-30 | 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 | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 36 | Null | 15 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89346
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CARISOPRODOL","submission":"CARISOPRODOL","actionType":"350MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)