Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SUSPENSION;ORAL | 125MG/5ML | 0 | PHENYTOIN | PHENYTOIN |
002 | SUSPENSION;ORAL | 125MG/5ML | 0 | PHENYTOIN | PHENYTOIN |
FDA Submissions
| ORIG | 1 | AP | 2001-01-31 | |
LABELING; Labeling | SUPPL | 5 | AP | 2010-01-26 | |
LABELING; Labeling | SUPPL | 6 | AP | 2014-01-15 | |
LABELING; Labeling | SUPPL | 8 | AP | 2014-01-15 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2014-01-15 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2021-07-02 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2021-07-02 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2021-07-02 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2021-07-02 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2021-07-02 | STANDARD |
Submissions Property Types
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 15 |
SUPPL | 11 | Null | 7 |
SUPPL | 12 | Null | 7 |
SUPPL | 15 | Null | 15 |
SUPPL | 20 | Null | 15 |
SUPPL | 22 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 40342
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"PHENYTOIN","activeIngredients":"PHENYTOIN","strength":"125MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PHENYTOIN","submission":"PHENYTOIN","actionType":"125MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)