ANDA 085113

IMPAX LABS

FDA Drug Application

Application #085113

Application Sponsors

ANDA 085113

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

10MG

0

CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1977-12-12
LABELING; Labeling	SUPPL	7	AP	1989-01-11
LABELING; Labeling	SUPPL	8	AP	1989-10-24
LABELING; Labeling	SUPPL	9	AP	1990-07-09
LABELING; Labeling	SUPPL	10	AP	1991-09-17
LABELING; Labeling	SUPPL	11	AP	1992-09-17

Submissions Property Types

ORIG	1	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85113
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORDIAZEPOXIDE HYDROCHLORIDE","submission":"CHLORDIAZEPOXIDE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)