Documents
Application Sponsors
| NDA 021996 | BAUSCH AND LOMB | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.025% BASE | 1 | ALAWAY | KETOTIFEN FUMARATE |
| 002 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.035% BASE | 1 | ALAWAY | KETOTIFEN FUMARATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2006-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2015-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-04-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 17 | Null | 6 |
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 21996
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"ALAWAY","activeIngredients":"KETOTIFEN FUMARATE","strength":"EQ 0.025% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ALAWAY","activeIngredients":"KETOTIFEN FUMARATE","strength":"EQ 0.035% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/11\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021996Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2007","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021996s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2007","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021996s001lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ALAWAY","submission":"KETOTIFEN FUMARATE","actionType":"EQ 0.025% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ALAWAY","submission":"KETOTIFEN FUMARATE","actionType":"EQ 0.035% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-02-11
)
)