Application Sponsors
Marketing Status
Application Products
| 002 | SUSPENSION/DROPS;OPHTHALMIC | EQ 0.35% BASE;10,000 UNITS/ML;0.5% | 0 | POLY-PRED | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1963-05-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 3 | AP | 1984-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1983-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1984-02-10 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1963-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-09-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1985-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1964-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1987-08-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1995-08-03 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1965-12-02 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1979-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1980-03-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1981-06-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1982-08-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1998-05-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2001-04-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2002-02-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2002-04-12 | |
| LABELING; Labeling | SUPPL | 38 | AP | 2003-03-19 | STANDARD |
Submissions Property Types
| SUPPL | 1 | 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 | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 50081
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"POLY-PRED","activeIngredients":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE","strength":"EQ 0.35% BASE;10,000 UNITS\/ML;0.5%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"POLY-PRED","submission":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE","actionType":"EQ 0.35% BASE;10,000 UNITS\/ML;0.5%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)