ANDA 216872

MICRO LABS

FDA Drug Application

Application #216872

Application Sponsors

ANDA 216872

MICRO LABS

Marketing Status

• Prescription: 001
• Prescription: 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

2022-10-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216872
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MISOPROSTOL","activeIngredients":"MISOPROSTOL","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MISOPROSTOL","activeIngredients":"MISOPROSTOL","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-17
        )

)