NDA 214028

ABBVIE INC

FDA Drug Application

Application #214028

Documents

• Letter: 2021-10-29
• Label: 2021-10-29
• Review: 2022-05-09
• Letter: 2022-08-17
• Label: 2022-08-17

Application Sponsors

NDA 214028

ABBVIE INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1.25%

0

VUITY

PILOCARPINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-10-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214028
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VUITY","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"1.25%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214028s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214028s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214028Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-28
        )

)