Application Sponsors
| ANDA 064053 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OTIC | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | 0 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1995-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-09-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-10-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-02-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-07-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-11-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-03-28 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2002-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2002-04-17 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2006-07-03 | |
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 | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | 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 | 24 | Null | 0 |
TE Codes
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 64053
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE","activeIngredients":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE","submission":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)