ANDA 086213

IMPAX LABS

FDA Drug Application

Application #086213

Application Sponsors

ANDA 086213

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

5MG

0

CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1979-07-10
LABELING; Labeling	SUPPL	2	AP	1991-02-04
LABELING; Labeling	SUPPL	3	AP	1991-02-04
LABELING; Labeling	SUPPL	4	AP	1991-09-17
LABELING; Labeling	SUPPL	5	AP	1991-10-09
LABELING; Labeling	SUPPL	6	AP	1992-01-10

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86213
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORDIAZEPOXIDE HYDROCHLORIDE","submission":"CHLORDIAZEPOXIDE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)