Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SUSPENSION/DROPS;OPHTHALMIC | 0.1%;0.3% | 1 | TOBRADEX | DEXAMETHASONE; TOBRAMYCIN |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1988-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-08-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1991-12-31 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1994-10-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-08-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-11-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-11-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1996-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1996-09-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1997-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1999-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1998-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-08-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1999-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1999-02-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-04-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2000-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2001-04-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2001-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2002-08-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2002-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2003-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2020-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2021-05-14 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2021-05-14 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | 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 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 46 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 50592
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)