Application Sponsors
| ANDA 087506 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.1% | 0 | OPCON | NAPHAZOLINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1981-12-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1992-01-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1994-04-20 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1995-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1995-07-07 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 10 | 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 | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 87506
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"OPCON","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OPCON","submission":"NAPHAZOLINE HYDROCHLORIDE","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)