Application Sponsors
| ANDA 089286 | SUN PHARM INDUSTRIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | CHLORTHALIDONE | CHLORTHALIDONE |
| 002 | TABLET;ORAL | 25MG | 0 | CHLORTHALIDONE | CHLORTHALIDONE |
FDA Submissions
| ORIG | 1 | AP | 1986-07-21 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1991-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1995-06-22 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1996-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1997-12-05 | |
| 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 | 2002-07-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2002-11-08 | |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | 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 | 14 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89286
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)