Application Sponsors
| ANDA 064063 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | OINTMENT;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | 0 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1994-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-10-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-07-23 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1997-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-10-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1999-03-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-08-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-11-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-08-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-08-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-08-27 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2020-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2020-02-07 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | 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 | 41 | Null | 7 |
| SUPPL | 42 | Null | 15 |
TE Codes
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 64063
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE","activeIngredients":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"0.1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE","submission":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"0.1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)