Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 10,000 UNITS/ML;EQ 1MG BASE/ML | 1 | POLYTRIM | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1988-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-07-02 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1992-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1993-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-08-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1997-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-05-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-12-05 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2000-12-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-04-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2003-03-19 | STANDARD |
Submissions Property Types
| SUPPL | 2 | 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 | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
TE Codes
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 50567
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"POLYTRIM","activeIngredients":"POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","strength":"10,000 UNITS\/ML;EQ 1MG BASE\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"POLYTRIM","submission":"POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","actionType":"10,000 UNITS\/ML;EQ 1MG BASE\/ML","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)