Application Sponsors
Marketing Status
Application Products
001 | OINTMENT;OPHTHALMIC | 1% | 0 | CHLOROPTIC S.O.P. | CHLORAMPHENICOL |
FDA Submissions
| ORIG | 1 | AP | 1970-07-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-05-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-07-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-02-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-02-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-02-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-02-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-09-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-11-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-12-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-08-15 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 61187
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"CHLOROPTIC S.O.P.","activeIngredients":"CHLORAMPHENICOL","strength":"1%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLOROPTIC S.O.P.","submission":"CHLORAMPHENICOL","actionType":"1%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)