ANDA 200158

SANDOZ

FDA Drug Application

Application #200158

Application Sponsors

ANDA 200158

SANDOZ

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

2013-05-09

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SANDOZ

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200158
            [companyName] => SANDOZ
            [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":"05\/09\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-05-09
        )

)