Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | CAPSULE;ORAL | EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TOFRANIL-PM | IMIPRAMINE PAMOATE |
| 002 | CAPSULE;ORAL | EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TOFRANIL-PM | IMIPRAMINE PAMOATE |
| 003 | CAPSULE;ORAL | EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TOFRANIL-PM | IMIPRAMINE PAMOATE |
| 004 | CAPSULE;ORAL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TOFRANIL-PM | IMIPRAMINE PAMOATE |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1973-03-11 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 1974-05-22 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 1974-05-22 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 1974-05-22 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 1974-05-22 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 1974-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1974-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1974-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1974-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1974-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1974-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1974-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1974-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1975-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1977-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1979-01-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1979-12-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1979-12-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1979-06-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1979-06-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1980-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1980-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1980-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1981-02-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1986-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1983-05-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1984-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 1984-03-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1984-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 1985-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1985-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1985-11-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1986-05-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 51 | AP | 1987-08-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1989-04-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1989-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1989-10-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1989-10-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1990-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1991-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 1992-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1993-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2000-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2000-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2000-03-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1997-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1999-04-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2000-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2000-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2002-01-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 2002-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2004-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2005-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2007-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 76 | AP | 2012-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 77 | AP | 2014-07-10 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 78 | AP | 2014-07-28 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | 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 | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 76 | Null | 15 |
| SUPPL | 77 | Null | 6 |
| SUPPL | 78 | Null | 6 |
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 17090
[companyName] => SPECGX LLC
[docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM326090.pdf"]
[products] => [{"drugName":"TOFRANIL-PM","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TOFRANIL-PM","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TOFRANIL-PM","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TOFRANIL-PM","activeIngredients":"IMIPRAMINE PAMOATE","strength":"EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/28\/2014","submission":"SUPPL-78","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017090s078lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2014","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017090s077lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017090s076lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2007","submission":"SUPPL-74","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017090s74lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2005","submission":"SUPPL-70","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/17090s070lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TOFRANIL-PM","submission":"IMIPRAMINE PAMOATE","actionType":"EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TOFRANIL-PM","submission":"IMIPRAMINE PAMOATE","actionType":"EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TOFRANIL-PM","submission":"IMIPRAMINE PAMOATE","actionType":"EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TOFRANIL-PM","submission":"IMIPRAMINE PAMOATE","actionType":"EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-07-28
)
)