Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 30MG EXTENDED | 0 | DILANTIN | PHENYTOIN SODIUM |
| 002 | CAPSULE;ORAL | 100MG EXTENDED | 0 | DILANTIN | PHENYTOIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1976-08-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-05-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1982-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1984-04-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1984-04-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-04-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1984-06-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1986-10-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1988-08-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-08-25 | |
| BIOEQUIV; Bioequivalence | SUPPL | 26 | AP | 1990-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1993-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1997-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1997-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1997-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1996-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1998-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1998-03-25 | |
| LABELING; Labeling | SUPPL | 40 | AP | 2003-12-09 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2007-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2007-08-08 | |
| LABELING; Labeling | SUPPL | 56 | AP | 2009-07-09 | |
| LABELING; Labeling | SUPPL | 60 | AP | 2009-05-06 | |
| LABELING; Labeling | SUPPL | 62 | AP | 2014-02-27 | |
| REMS; REMS | SUPPL | 64 | AP | 2011-04-08 | |
| LABELING; Labeling | SUPPL | 67 | AP | 2012-11-27 | |
| LABELING; Labeling | SUPPL | 70 | AP | 2013-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2013-12-26 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2014-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2014-07-03 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2015-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2017-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 77 | AP | 2017-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 78 | AP | 2017-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2017-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 80 | AP | 2017-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 81 | AP | 2017-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 82 | AP | 2017-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 84 | AP | 2017-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 85 | AP | 2018-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 86 | AP | 2020-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 87 | AP | 2021-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 88 | AP | 2022-09-07 | STANDARD |
Submissions Property Types
| 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 | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 60 | Null | 7 |
| SUPPL | 62 | Null | 15 |
| SUPPL | 67 | Null | 15 |
| SUPPL | 70 | Null | 15 |
| SUPPL | 71 | Null | 15 |
| SUPPL | 72 | Null | 31 |
| SUPPL | 73 | Null | 15 |
| SUPPL | 74 | Null | 15 |
| SUPPL | 75 | Null | 7 |
| SUPPL | 77 | Null | 15 |
| SUPPL | 78 | Null | 7 |
| SUPPL | 79 | Null | 7 |
| SUPPL | 80 | Null | 7 |
| SUPPL | 81 | Null | 15 |
| SUPPL | 82 | Null | 15 |
| SUPPL | 84 | Null | 15 |
| SUPPL | 85 | Null | 15 |
| SUPPL | 86 | Null | 7 |
| SUPPL | 87 | Null | 7 |
| SUPPL | 88 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 84349
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)