Application Sponsors
Marketing Status
Application Products
| 001 | OINTMENT;OPHTHALMIC | 0.2%;10% | 0 | BLEPHAMIDE S.O.P. | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1986-12-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1990-03-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1992-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-06-29 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1993-12-02 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1995-03-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-06-24 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1998-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-09-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-08-15 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | 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 |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 87748
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"BLEPHAMIDE S.O.P.","activeIngredients":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","strength":"0.2%;10%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BLEPHAMIDE S.O.P.","submission":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","actionType":"0.2%;10%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)