ANDA 201089

ACTAVIS LABS FL INC

FDA Drug Application

Application #201089

Documents

• Letter: 2012-07-11
• Review: 2012-10-12

Application Sponsors

ANDA 201089

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	50MG;0.2MG	0	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL
002	TABLET, DELAYED RELEASE;ORAL	75MG;0.2MG	0	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-07-09
LABELING; Labeling	SUPPL	2	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-09-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201089
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM AND MISOPROSTOL","activeIngredients":"DICLOFENAC SODIUM; MISOPROSTOL","strength":"50MG;0.2MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DICLOFENAC SODIUM AND MISOPROSTOL","activeIngredients":"DICLOFENAC SODIUM; MISOPROSTOL","strength":"75MG;0.2MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201089Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/201089Orig1s000BioeqR.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/16\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/16\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-09-16
        )

)