NDA 014740

ROCHE

FDA Drug Application

Application #014740

Application Sponsors

NDA 014740

ROCHE

Marketing Status

• Discontinued: 002
• Discontinued: 004
• Discontinued: 006

Application Products

002	TABLET;ORAL	5MG;0.2MG	0	MENRIUM 5-2	CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED
004	TABLET;ORAL	5MG;0.4MG	0	MENRIUM 5-4	CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED
006	TABLET;ORAL	10MG;0.4MG	0	MENRIUM 10-4	CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1966-07-28	STANDARD
LABELING; Labeling	SUPPL	19	AP	1996-03-27
LABELING; Labeling	SUPPL	30	AP	1996-03-27
LABELING; Labeling	SUPPL	31	AP	1996-03-27
EFFICACY; Efficacy	SUPPL	34	AP	1996-03-27
EFFICACY; Efficacy	SUPPL	36	AP	1978-10-06
EFFICACY; Efficacy	SUPPL	37	AP	1996-03-27
EFFICACY; Efficacy	SUPPL	38	AP	1996-03-27
EFFICACY; Efficacy	SUPPL	40	AP	1996-03-27
EFFICACY; Efficacy	SUPPL	41	AP	1980-03-06
LABELING; Labeling	SUPPL	42	AP	1996-03-27
LABELING; Labeling	SUPPL	46	AP	1983-06-24
LABELING; Labeling	SUPPL	47	AP	1983-06-24
LABELING; Labeling	SUPPL	48	AP	1996-03-27
LABELING; Labeling	SUPPL	51	AP	1989-03-01
LABELING; Labeling	SUPPL	52	AP	1989-03-01
LABELING; Labeling	SUPPL	53	AP	1989-03-01
LABELING; Labeling	SUPPL	54	AP	1996-03-27

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14740
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MENRIUM 10-4","activeIngredients":"CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED","strength":"10MG;0.4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MENRIUM 5-2","activeIngredients":"CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED","strength":"5MG;0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MENRIUM 5-4","activeIngredients":"CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED","strength":"5MG;0.4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MENRIUM 10-4","submission":"CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED","actionType":"10MG;0.4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MENRIUM 5-2","submission":"CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED","actionType":"5MG;0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MENRIUM 5-4","submission":"CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED","actionType":"5MG;0.4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)