Application Sponsors
| ANDA 074443 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 4% | 0 | CROLOM | CROMOLYN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1995-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-07-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-03-26 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1999-06-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1999-12-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-11-27 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2002-12-09 | |
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 | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | 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 |
| SUPPL | 19 | Null | 0 |
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 74443
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"CROLOM","activeIngredients":"CROMOLYN SODIUM","strength":"4%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CROLOM","submission":"CROMOLYN SODIUM","actionType":"4%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)