NDA 022388

JOHNSON AND JOHNSON VISION CARE, INC

FDA Drug Application

Application #022388

Documents

• Letter: 2022-02-28
• Label: 2022-03-01
• Letter: 2022-03-02
• Review: 2022-09-19

Application Sponsors

NDA 022388

JOHNSON AND JOHNSON VISION CARE, INC

Marketing Status

• Prescription: 001

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

ORIG

1

Null

6

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
        )

)