ANDA 090359

BRECKENRIDGE

FDA Drug Application

Application #090359

Application Sponsors

ANDA 090359

BRECKENRIDGE

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

250MG

0

MEFENAMIC ACID

MEFENAMIC ACID

FDA Submissions

	ORIG	1	AP	2013-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-12-30
LABELING; Labeling	SUPPL	3	AP	2019-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90359
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEFENAMIC ACID","activeIngredients":"MEFENAMIC ACID","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEFENAMIC ACID","submission":"MEFENAMIC ACID","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)