ANDA 201000

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #201000

Documents

• Letter: 2014-10-29

Application Sponsors

ANDA 201000

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.3%

0

ADAPALENE

ADAPALENE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2014-10-27

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201000
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE","activeIngredients":"ADAPALENE","strength":"0.3%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201000Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-27
        )

)