Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | ALBALON | NAPHAZOLINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1972-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1983-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1987-06-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1988-01-20 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1991-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1992-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1994-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1995-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1995-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1997-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1997-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1999-03-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1998-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2000-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2001-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2001-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2002-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2002-11-15 | |
Submissions Property Types
| SUPPL | 20 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 42 | Null | 0 |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 80248
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"ALBALON","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE","strength":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ALBALON","submission":"NAPHAZOLINE HYDROCHLORIDE","actionType":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)