Application Sponsors
| NDA 018471 | BAYER HEALTHCARE LLC | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.025% | 0 | OCUCLEAR | OXYMETAZOLINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1986-05-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-08-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-05-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-08-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-03-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1989-06-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1989-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1990-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-06-06 | STANDARD |
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 | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
CDER Filings
BAYER HEALTHCARE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 18471
[companyName] => BAYER HEALTHCARE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"OCUCLEAR","activeIngredients":"OXYMETAZOLINE HYDROCHLORIDE","strength":"0.025%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OCUCLEAR","submission":"OXYMETAZOLINE HYDROCHLORIDE","actionType":"0.025%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)