Application Sponsors
| ANDA 089247 | SUN PHARM INDUSTRIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 20MG | 0 | PREDNISONE | PREDNISONE |
| 002 | TABLET;ORAL | 5MG | 0 | PREDNISONE | PREDNISONE |
| 003 | TABLET;ORAL | 10MG | 0 | PREDNISONE | PREDNISONE |
FDA Submissions
| ORIG | 1 | AP | 1985-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-09-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1990-02-01 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1990-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-01-12 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1994-01-06 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1994-10-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-06-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-08-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-06-14 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2002-05-20 | |
| LABELING; Labeling | SUPPL | 17 | AP | 2001-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-12-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-12-20 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | 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 | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89247
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)