ANDA 204355

MICRO LABS

FDA Drug Application

Application #204355

Application Sponsors

ANDA 204355

MICRO LABS

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

UNKNOWN;

ORIG

1

AP

2021-07-15

STANDARD

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204355
            [companyName] => MICRO LABS
            [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\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-15
        )

)