Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 10% | 0 | BLEPH-10 | SULFACETAMIDE SODIUM |
| 002 | SOLUTION/DROPS;OPHTHALMIC | 30% | 0 | BLEPH-30 | SULFACETAMIDE SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1971-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1982-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1982-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1982-07-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1982-08-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1983-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1986-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1986-10-24 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1991-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1988-03-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1991-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1991-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1991-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1991-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1991-12-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1989-05-02 | |
| LABELING; Labeling | SUPPL | 35 | AP | 1991-12-12 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1993-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1993-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1994-09-27 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1994-06-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1997-11-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1997-11-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1998-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2000-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2001-02-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2001-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2001-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2002-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2002-11-15 | |
Submissions Property Types
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
TE Codes
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 80028
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"BLEPH-10","activeIngredients":"SULFACETAMIDE SODIUM","strength":"10%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"BLEPH-30","activeIngredients":"SULFACETAMIDE SODIUM","strength":"30%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BLEPH-10","submission":"SULFACETAMIDE SODIUM","actionType":"10%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BLEPH-30","submission":"SULFACETAMIDE SODIUM","actionType":"30%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)