Application Sponsors
| ANDA 074063 | SUN PHARM INDUSTRIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | PINDOLOL | PINDOLOL |
| 002 | TABLET;ORAL | 10MG | 0 | PINDOLOL | PINDOLOL |
FDA Submissions
| ORIG | 1 | AP | 1994-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-04-17 | |
| 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 | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2001-02-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-12-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2015-03-09 | UNKNOWN |
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 | 17 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 74063
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"PINDOLOL","activeIngredients":"PINDOLOL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PINDOLOL","activeIngredients":"PINDOLOL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PINDOLOL","submission":"PINDOLOL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PINDOLOL","submission":"PINDOLOL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)