Application Sponsors
| ANDA 064120 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 10,000 UNITS/ML;EQ 1MG BASE/ML | 0 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1997-02-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-08-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-04-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-11-17 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-09-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-11-27 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2002-06-13 | |
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 | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
TE Codes
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 64120
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE","activeIngredients":"POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","strength":"10,000 UNITS\/ML;EQ 1MG BASE\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE","submission":"POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","actionType":"10,000 UNITS\/ML;EQ 1MG BASE\/ML","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)