Application Sponsors
Marketing Status
Application Products
001 | OINTMENT;OPHTHALMIC | 10% | 0 | CETAMIDE | SULFACETAMIDE SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1972-09-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1990-03-09 | |
LABELING; Labeling | SUPPL | 6 | AP | 1989-09-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1990-03-09 | |
LABELING; Labeling | SUPPL | 8 | AP | 1991-07-05 | |
LABELING; Labeling | SUPPL | 9 | AP | 1993-08-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1992-08-19 | |
LABELING; Labeling | SUPPL | 11 | AP | 1993-08-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-08-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-04-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-04-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-12-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-03-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-01-18 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | 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 |
CDER Filings
ALCON
cder:Array
(
[0] => Array
(
[ApplNo] => 80021
[companyName] => ALCON
[docInserts] => ["",""]
[products] => [{"drugName":"CETAMIDE","activeIngredients":"SULFACETAMIDE SODIUM","strength":"10%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CETAMIDE","submission":"SULFACETAMIDE SODIUM","actionType":"10%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)