Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
Application Products
| 001 | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE |
| 005 | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE |
| 006 | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE |
| 007 | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1961-04-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1981-03-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1975-09-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1975-09-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 1975-09-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 38 | AP | 1975-09-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 39 | AP | 1976-10-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1976-08-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 42 | AP | 1976-09-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1976-08-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1977-03-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1978-01-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1980-01-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1981-03-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 52 | AP | 1979-11-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 53 | AP | 1980-01-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 54 | AP | 1980-03-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1981-03-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1981-09-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1981-03-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 59 | AP | 1980-06-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 60 | AP | 1980-09-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 61 | AP | 1981-03-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1981-06-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1983-05-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 65 | AP | 1984-05-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1983-05-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 68 | AP | 1983-03-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1984-03-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1984-08-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 71 | AP | 1984-09-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 72 | AP | 1985-09-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 73 | AP | 1986-07-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 1986-04-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1988-02-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 76 | AP | 1991-06-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1988-12-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1988-04-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 79 | AP | 1991-06-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 1989-07-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 81 | AP | 1991-06-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 82 | AP | 1994-06-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 83 | AP | 1994-06-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 84 | AP | 2000-04-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 85 | AP | 1995-07-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 86 | AP | 2000-04-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 87 | AP | 1996-12-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 88 | AP | 2000-04-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 1998-12-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 90 | AP | 2000-04-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 91 | AP | 2001-01-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 92 | AP | 2001-03-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 93 | AP | 2003-07-29 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 71 | Null | 0 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 74 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 0 |
| SUPPL | 80 | Null | 0 |
| SUPPL | 81 | Null | 0 |
| SUPPL | 82 | Null | 0 |
| SUPPL | 83 | Null | 0 |
| SUPPL | 84 | Null | 0 |
| SUPPL | 85 | Null | 0 |
| SUPPL | 86 | Null | 0 |
| SUPPL | 87 | Null | 0 |
| SUPPL | 88 | Null | 0 |
| SUPPL | 89 | Null | 0 |
| SUPPL | 90 | Null | 0 |
| SUPPL | 91 | Null | 0 |
| SUPPL | 92 | Null | 0 |
| SUPPL | 93 | Null | 0 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 12703
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)