ANDA 210201

ZYDUS PHARMS

FDA Drug Application

Application #210201

Application Sponsors

ANDA 210201

ZYDUS PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	0.1MG	0	MISOPROSTOL	MISOPROSTOL
002	TABLET;ORAL	0.2MG	0	MISOPROSTOL	MISOPROSTOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210201
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MISOPROSTOL","activeIngredients":"MISOPROSTOL","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MISOPROSTOL","activeIngredients":"MISOPROSTOL","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-02
        )

)