ANDA 206952

ACTAVIS LABS FL INC

FDA Drug Application

Application #206952

Documents

• REMS: 2016-11-04

Application Sponsors

ANDA 206952

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

001	CAPSULE, EXTENDED RELEASE; ORAL	10MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
005	CAPSULE, EXTENDED RELEASE;ORAL	40MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-04-05

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206952
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-05
        )

)