Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 400MG | 0 | TONOCARD | TOCAINIDE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 600MG | 0 | TONOCARD | TOCAINIDE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1984-11-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1985-02-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-02-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-01-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-01-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1985-05-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 1985-05-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1986-04-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1985-09-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-02-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-08-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1987-01-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 1987-08-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1987-06-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1987-07-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-04-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1989-12-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1989-07-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 1992-09-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1992-10-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 1995-11-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1997-11-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1997-10-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 1999-07-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-06-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2001-01-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 2001-10-24 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | 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 | 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 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 18257
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"TONOCARD","activeIngredients":"TOCAINIDE HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TONOCARD","activeIngredients":"TOCAINIDE HYDROCHLORIDE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TONOCARD","submission":"TOCAINIDE HYDROCHLORIDE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TONOCARD","submission":"TOCAINIDE HYDROCHLORIDE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)