Documents
Application Sponsors
Marketing Status
Application Products
| 002 | SUSPENSION/DROPS;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | 1 | MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1963-06-06 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1971-10-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1973-02-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1976-03-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1977-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-03-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-06-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-07-27 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-08-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-03-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1998-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-03-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-08-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-10-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-12-11 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2008-04-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-05-27 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2017-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2017-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2021-05-14 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | 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 | 31 | Null | 0 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 50023
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)