Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.1% | 0 | NAPHAZOLINE HYDROCHLORIDE | NAPHAZOLINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1974-08-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1987-08-07 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1991-07-15 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1991-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-09-14 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1995-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1996-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-08-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-09-30 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2012-11-30 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | 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 | 23 | Null | 15 |
CDER Filings
AKORN INC
cder:Array
(
[0] => Array
(
[ApplNo] => 83590
[companyName] => AKORN INC
[docInserts] => ["",""]
[products] => [{"drugName":"NAPHAZOLINE HYDROCHLORIDE","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NAPHAZOLINE HYDROCHLORIDE","submission":"NAPHAZOLINE HYDROCHLORIDE","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)