Application Sponsors
| ANDA 064068 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | OINTMENT;OPHTHALMIC | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | 0 | NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1995-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-09-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-10-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-05-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-03-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-03-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-04-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-11-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-07-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-08-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-07-18 | |
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 |
TE Codes
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 64068
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE","activeIngredients":"BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"400 UNITS\/GM;1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE","submission":"BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"400 UNITS\/GM;1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)