ANDA 207438

MICRO LABS

FDA Drug Application

Application #207438

Application Sponsors

ANDA 207438

MICRO LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	25MG	0	METHAZOLAMIDE	METHAZOLAMIDE
002	TABLET;ORAL	50MG	0	METHAZOLAMIDE	METHAZOLAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207438
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHAZOLAMIDE","activeIngredients":"METHAZOLAMIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHAZOLAMIDE","activeIngredients":"METHAZOLAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-05
        )

)