NDA 013263

ROCHE

FDA Drug Application

Application #013263

Documents

• Letter: 2004-06-29
• Letter: 2008-05-14
• Letter: 2002-02-12
• Label: 2008-06-05
• Letter: 2002-02-07
• Letter: 2008-05-14
• Letter: 2001-05-09
• Letter: 2013-10-24
• Review: 2007-07-06
• Label: 2013-10-25
• Review: 2007-07-06
• Review: 2007-07-06
• Review: 2006-10-25
• Review: 2007-07-09
• Label: 2016-12-20
• Letter: 2016-12-22
• Medication Guide: 2016-12-29
• Letter: 2021-02-09
• Label: 2021-02-12
• Letter: 2023-01-17
• Label: 2023-01-17
• Medication Guide: 2023-01-17

Application Sponsors

NDA 013263

ROCHE

Marketing Status

• Prescription: 002
• Prescription: 004
• Prescription: 006

Application Products

002	TABLET;ORAL	2MG	1	VALIUM	DIAZEPAM
004	TABLET;ORAL	5MG	1	VALIUM	DIAZEPAM
006	TABLET;ORAL	10MG	1	VALIUM	DIAZEPAM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1963-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1974-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1975-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1975-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1975-08-25	STANDARD
LABELING; Labeling	SUPPL	39	AP	1976-08-27
LABELING; Labeling	SUPPL	40	AP	1976-10-27
LABELING; Labeling	SUPPL	41	AP	1976-12-14
LABELING; Labeling	SUPPL	42	AP	1977-09-21
LABELING; Labeling	SUPPL	43	AP	1978-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1980-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1979-04-04	STANDARD
LABELING; Labeling	SUPPL	46	AP	1979-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1979-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1981-01-09	STANDARD
LABELING; Labeling	SUPPL	49	AP	1980-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1980-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1980-10-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1981-07-17	STANDARD
LABELING; Labeling	SUPPL	54	AP	1981-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1983-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1982-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1982-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1982-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1982-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1982-10-18	STANDARD
LABELING; Labeling	SUPPL	62	AP	1982-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1982-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1982-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1983-01-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	1983-01-20	STANDARD
LABELING; Labeling	SUPPL	67	AP	1984-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1984-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1985-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1986-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1988-01-20	STANDARD
LABELING; Labeling	SUPPL	72	AP	2002-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1988-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1989-10-26	STANDARD
LABELING; Labeling	SUPPL	75	AP	2002-02-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1997-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1997-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1997-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1998-09-04	STANDARD
LABELING; Labeling	SUPPL	80	AP	2008-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	2000-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	82	AP	2001-05-09	STANDARD
LABELING; Labeling	SUPPL	83	AP	2008-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	2001-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	2001-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	86	AP	2002-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	2013-04-19	STANDARD
LABELING; Labeling	SUPPL	92	AP	2013-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	2015-07-30	STANDARD
LABELING; Labeling	SUPPL	94	AP	2016-12-16	901 REQUIRED
LABELING; Labeling	SUPPL	96	AP	2021-02-05	901 REQUIRED
LABELING; Labeling	SUPPL	97	AP	2023-01-13	STANDARD

Submissions Property Types

SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	53	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	0
SUPPL	79	Null	0
SUPPL	81	Null	0
SUPPL	82	Null	0
SUPPL	84	Null	0
SUPPL	85	Null	0
SUPPL	86	Null	0
SUPPL	91	Null	0
SUPPL	92	Null	6
SUPPL	93	Null	0
SUPPL	94	Null	15
SUPPL	96	Null	15
SUPPL	97	Null	6

TE Codes

002	Prescription	AB
004	Prescription	AB
006	Prescription	AB

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13263
            [companyName] => ROCHE
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/013263s094lbl.pdf#page=14"]
            [products] => [{"drugName":"VALIUM","activeIngredients":"DIAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VALIUM","activeIngredients":"DIAZEPAM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VALIUM","activeIngredients":"DIAZEPAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/16\/2016","submission":"SUPPL-94","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/013263s094lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-94","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/013263s094lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2013","submission":"SUPPL-92","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/013263s092lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2008","submission":"SUPPL-83","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/013263s083lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VALIUM","submission":"DIAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VALIUM","submission":"DIAZEPAM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VALIUM","submission":"DIAZEPAM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-12-16
        )

)