Documents
Application Sponsors
| NDA 021664 | BAUSCH AND LOMB INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | XIBROM | BROMFENAC SODIUM |
| 002 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BROMDAY | BROMFENAC SODIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2009-06-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2010-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2014-01-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 2014-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2014-12-11 | STANDARD |
Submissions Property Types
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 0 |
CDER Filings
BAUSCH AND LOMB INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21664
[companyName] => BAUSCH AND LOMB INC
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[labels] => [{"actionDate":"01\/27\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021664s014s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2014","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021664s014s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2010","submission":"SUPPL-13","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021664s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2009","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021664s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2006","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021664s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021664lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BROMDAY","submission":"BROMFENAC SODIUM","actionType":"EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"XIBROM","submission":"BROMFENAC SODIUM","actionType":"EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-01-27
)
)