Application Sponsors
| ANDA 085031 | ANI PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
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 |
FDA Submissions
| ORIG | 1 | AP | 1976-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 239 | AP | 1983-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 244 | AP | 1982-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 248 | AP | 1983-12-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 249 | AP | 1984-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 250 | AP | 1984-07-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 251 | AP | 1985-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 252 | AP | 1984-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 254 | AP | 1985-09-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 255 | AP | 1985-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 256 | AP | 1985-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 257 | AP | 1985-12-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 259 | AP | 1986-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 260 | AP | 1986-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 261 | AP | 1986-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 262 | AP | 1986-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 263 | AP | 1987-09-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 265 | AP | 1987-11-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 266 | AP | 1987-09-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 268 | AP | 1988-03-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 269 | AP | 1988-03-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 271 | AP | 1989-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 272 | AP | 1992-06-10 | |
| LABELING; Labeling | SUPPL | 273 | AP | 1991-12-31 | |
| LABELING; Labeling | SUPPL | 276 | AP | 1992-06-12 | |
| LABELING; Labeling | SUPPL | 277 | AP | 1993-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 278 | AP | 1994-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 279 | AP | 1994-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 280 | AP | 1994-09-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 281 | AP | 1994-11-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 282 | AP | 1995-02-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 283 | AP | 1995-02-15 | |
| LABELING; Labeling | SUPPL | 284 | AP | 1995-06-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 285 | AP | 1997-06-18 | |
| LABELING; Labeling | SUPPL | 286 | AP | 2014-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 287 | AP | 2016-04-25 | STANDARD |
Submissions Property Types
| SUPPL | 239 | Null | 0 |
| SUPPL | 244 | Null | 0 |
| SUPPL | 248 | Null | 0 |
| SUPPL | 249 | Null | 0 |
| SUPPL | 250 | Null | 0 |
| SUPPL | 251 | Null | 0 |
| SUPPL | 252 | Null | 0 |
| SUPPL | 254 | Null | 0 |
| SUPPL | 255 | Null | 0 |
| SUPPL | 256 | Null | 0 |
| SUPPL | 257 | Null | 0 |
| SUPPL | 259 | Null | 0 |
| SUPPL | 260 | Null | 0 |
| SUPPL | 261 | Null | 0 |
| SUPPL | 262 | Null | 0 |
| SUPPL | 263 | Null | 0 |
| SUPPL | 265 | Null | 0 |
| SUPPL | 266 | Null | 0 |
| SUPPL | 268 | Null | 0 |
| SUPPL | 269 | Null | 0 |
| SUPPL | 270 | Null | 0 |
| SUPPL | 271 | Null | 0 |
| SUPPL | 272 | Null | 0 |
| SUPPL | 278 | Null | 0 |
| SUPPL | 279 | Null | 0 |
| SUPPL | 280 | Null | 0 |
| SUPPL | 281 | Null | 0 |
| SUPPL | 282 | Null | 0 |
| SUPPL | 283 | Null | 0 |
| SUPPL | 285 | Null | 0 |
| SUPPL | 286 | Null | 15 |
| SUPPL | 287 | Null | 15 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 85031
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)