Documents
Application Sponsors
NDA 022388 | JOHNSON AND JOHNSON VISION CARE, INC | |
Marketing Status
Application Products
001 | SOLUTION;OPTICAL | 19MCG PER LENS | 0 | ACUVUE THERAVISION WITH KETOTIFEN | ETAFILCON A LENS WITH KETOTIFEN |
FDA Submissions
TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination | ORIG | 1 | AP | 2022-02-25 | STANDARD |
Submissions Property Types
CDER Filings
JOHNSON AND JOHNSON VISION CARE, INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22388
[companyName] => JOHNSON AND JOHNSON VISION CARE, INC
[docInserts] => ["",""]
[products] => [{"drugName":"ACUVUE THERAVISION WITH KETOTIFEN","activeIngredients":"ETAFILCON A LENS WITH KETOTIFEN","strength":"19MCG PER LENS","dosageForm":"SOLUTION;OPTICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/25\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022388s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ACUVUE THERAVISION WITH KETOTIFEN","submission":"ETAFILCON A LENS WITH KETOTIFEN","actionType":"19MCG PER LENS","submissionClassification":"SOLUTION;OPTICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2022-02-25
)
)