Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 50MG PHENYTOIN NA/ML | 1 | CEREBYX | FOSPHENYTOIN SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1996-08-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2017-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2001-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2001-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2002-01-02 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2011-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2011-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2011-11-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 20 | AP | 2013-03-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2013-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2014-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2013-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2014-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2014-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2015-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2016-03-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2016-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2016-06-16 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2016-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2017-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2017-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2017-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2019-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2020-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2021-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2021-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2022-04-28 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 42 | Null | 15 |
| SUPPL | 45 | Null | 15 |
| SUPPL | 46 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20450
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
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)
)