Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 10MG BASE | 0 | AVENTYL HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 25MG BASE | 0 | AVENTYL HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1964-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1977-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1978-07-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1979-12-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1981-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1983-07-19 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1984-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1984-10-05 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1985-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1990-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1987-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1987-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1987-04-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1990-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 1990-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 1993-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 1993-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1992-05-22 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1993-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1993-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 1996-07-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1994-06-16 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 1996-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2000-08-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1998-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1998-06-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1998-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2000-08-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 14684
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)