Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.1% | 0 | NAPHCON FORTE | NAPHAZOLINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1974-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1987-08-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1989-04-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1993-06-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-06-04 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1993-04-06 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1996-07-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1995-10-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1996-01-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1996-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-03-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-04-28 | |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | 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 |
| SUPPL | 25 | Null | 0 |
CDER Filings
ALCON
cder:Array
(
[0] => Array
(
[ApplNo] => 80229
[companyName] => ALCON
[docInserts] => ["",""]
[products] => [{"drugName":"NAPHCON FORTE","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NAPHCON FORTE","submission":"NAPHAZOLINE HYDROCHLORIDE","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)