NDA 211911

ALLERGAN INC

FDA Drug Application

Application #211911

Documents

• Label: 2020-03-05
• Letter: 2020-03-05
• Review: 2020-08-27
• Label: 2020-11-04
• Letter: 2020-11-04

Application Sponsors

NDA 211911

ALLERGAN INC

Marketing Status

• Prescription: 001

Application Products

001

IMPLANT;OPHTHALMIC

10MCG

1

DURYSTA

BIMATOPROST

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2020-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ALLERGAN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211911
            [companyName] => ALLERGAN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DURYSTA","activeIngredients":"BIMATOPROST","strength":"10MCG","dosageForm":"IMPLANT;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/04\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211911s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211911s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211911Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-04
        )

)