Documents
Application Sponsors
Marketing Status
| Discontinued | 002 |
| Discontinued | 004 |
| Discontinued | 007 |
| Discontinued | 010 |
Application Products
| 002 | CAPSULE;ORAL | 500MG | 0 | PLACIDYL | ETHCHLORVYNOL |
| 004 | CAPSULE;ORAL | 100MG | 0 | PLACIDYL | ETHCHLORVYNOL |
| 007 | CAPSULE;ORAL | 200MG | 0 | PLACIDYL | ETHCHLORVYNOL |
| 010 | CAPSULE;ORAL | 750MG | 0 | PLACIDYL | ETHCHLORVYNOL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1961-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1976-03-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1976-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 1979-12-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1981-03-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1986-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 1983-12-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1981-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 1982-03-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1982-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1986-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1987-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1989-05-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1995-10-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1998-05-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | 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 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 10021
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"PLACIDYL","activeIngredients":"ETHCHLORVYNOL","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PLACIDYL","activeIngredients":"ETHCHLORVYNOL","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PLACIDYL","activeIngredients":"ETHCHLORVYNOL","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PLACIDYL","activeIngredients":"ETHCHLORVYNOL","strength":"750MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PLACIDYL","submission":"ETHCHLORVYNOL","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PLACIDYL","submission":"ETHCHLORVYNOL","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PLACIDYL","submission":"ETHCHLORVYNOL","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PLACIDYL","submission":"ETHCHLORVYNOL","actionType":"750MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)