NDA 016087

ROCHE

FDA Drug Application

Application #016087

Documents

• Letter: 2002-02-07
• Letter: 2002-02-07

Application Sponsors

NDA 016087

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

VALIUM

DIAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1966-08-24	STANDARD
LABELING; Labeling	SUPPL	22	AP	1974-06-20	STANDARD
LABELING; Labeling	SUPPL	23	AP	1974-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1974-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1974-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1975-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1975-11-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1976-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1976-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1977-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1978-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1980-03-15	STANDARD
LABELING; Labeling	SUPPL	37	AP	1979-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1979-04-09	STANDARD
LABELING; Labeling	SUPPL	39	AP	1979-05-31	STANDARD
LABELING; Labeling	SUPPL	40	AP	1979-11-02	STANDARD
LABELING; Labeling	SUPPL	41	AP	1979-07-20	STANDARD
LABELING; Labeling	SUPPL	42	AP	1980-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1981-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1981-04-16	STANDARD
LABELING; Labeling	SUPPL	45	AP	1981-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1981-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1981-08-24	STANDARD
LABELING; Labeling	SUPPL	48	AP	1981-11-13	STANDARD
LABELING; Labeling	SUPPL	49	AP	1981-11-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1981-11-19	STANDARD
LABELING; Labeling	SUPPL	51	AP	1982-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1982-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1982-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1982-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1982-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1983-03-01	STANDARD
LABELING; Labeling	SUPPL	58	AP	1983-04-06	STANDARD
LABELING; Labeling	SUPPL	59	AP	1983-03-14	STANDARD
LABELING; Labeling	SUPPL	60	AP	1983-03-14	STANDARD
LABELING; Labeling	SUPPL	61	AP	1983-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1983-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1983-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	1985-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1985-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1985-05-31	STANDARD
LABELING; Labeling	SUPPL	69	AP	1985-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1985-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1986-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1986-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1986-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1986-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1987-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1987-04-23	STANDARD
LABELING; Labeling	SUPPL	79	AP	2002-02-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	1993-05-25	STANDARD
LABELING; Labeling	SUPPL	81	AP	2002-02-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	82	AP	1997-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1997-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	1998-09-04	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	74	Null	0
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	0
SUPPL	79	Null	0
SUPPL	80	Null	0
SUPPL	81	Null	0
SUPPL	82	Null	0
SUPPL	83	Null	0
SUPPL	84	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16087
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALIUM","activeIngredients":"DIAZEPAM","strength":"5MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALIUM","submission":"DIAZEPAM","actionType":"5MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)