Application Sponsors
| ANDA 089399 | SUN PHARM INDS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG | 0 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 50MG | 0 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 75MG | 0 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE |
| 005 | TABLET;ORAL | 100MG | 0 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE |
| 006 | TABLET;ORAL | 150MG | 0 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1987-07-14 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1992-05-15 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1993-08-16 | |
| 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 | 1995-08-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-12-05 | |
| 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 | 2001-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-07-05 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2001-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-09-30 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2005-05-05 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2005-08-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2007-04-12 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2007-04-12 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2007-06-29 | |
| LABELING; Labeling | SUPPL | 34 | AP | 2007-11-21 | |
| LABELING; Labeling | SUPPL | 39 | AP | 2014-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2016-04-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2019-03-19 | UNKNOWN |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| 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 | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 45 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89399
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)