NDA 017970

ASTRAZENECA

FDA Drug Application

Application #017970

Documents

• Letter: 1998-10-29
• Letter: 2002-05-16
• Letter: 2003-06-22
• Letter: 2002-05-16
• Letter: 2004-12-30
• Letter: 2005-03-23
• Letter: 2006-03-23
• Label: 2002-05-16
• Label: 1998-10-29
• Label: 2003-06-22
• Label: 2002-08-30
• Label: 2004-12-30
• Letter: 2002-05-16
• Letter: 1998-10-29
• Letter: 2000-06-29
• Letter: 2002-08-30
• Letter: 2004-06-10
• Review: 1998-10-29
• Review: 2003-07-05
• Review: 2003-07-05
• Label: 1998-10-29
• Label: 2002-05-16
• Label: 2000-06-29
• Label: 2002-05-16
• Label: 2004-06-10
• Label: 2005-03-23
• Label: 2006-03-14
• Review: 2009-09-14
• Review: 1998-10-29
• Review: 2000-06-29
• Review: 2003-03-07
• Medication Guide: 2009-11-19
• Review: 2018-04-18

Application Sponsors

NDA 017970

ASTRAZENECA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	NOLVADEX	TAMOXIFEN CITRATE
002	TABLET;ORAL	EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	NOLVADEX	TAMOXIFEN CITRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1977-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-07-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	1979-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1978-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-12-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	1982-03-29
EFFICACY; Efficacy	SUPPL	7	AP	2009-03-13
LABELING; Labeling	SUPPL	8	AP	1985-12-10
LABELING; Labeling	SUPPL	9	AP	1985-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-04-05	STANDARD
LABELING; Labeling	SUPPL	12	AP	2009-03-13
LABELING; Labeling	SUPPL	14	AP	2009-03-13
EFFICACY; Efficacy	SUPPL	15	AP	1986-12-03
LABELING; Labeling	SUPPL	16	AP	2009-03-13
LABELING; Labeling	SUPPL	17	AP	1987-11-25
EFFICACY; Efficacy	SUPPL	18	AP	1989-03-16
LABELING; Labeling	SUPPL	19	AP	2009-03-13
EFFICACY; Efficacy	SUPPL	20	AP	1990-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1991-03-14	STANDARD
LABELING; Labeling	SUPPL	22	AP	2009-03-13
LABELING; Labeling	SUPPL	23	AP	2009-03-13
EFFICACY; Efficacy	SUPPL	24	AP	1993-04-01
LABELING; Labeling	SUPPL	25	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2009-03-13	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	1994-03-21	UNKNOWN
LABELING; Labeling	SUPPL	28	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	29	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	30	AP	1995-02-01	STANDARD
LABELING; Labeling	SUPPL	31	AP	1996-01-23	STANDARD
LABELING; Labeling	SUPPL	32	AP	1996-01-23	STANDARD
LABELING; Labeling	SUPPL	33	AP	1996-01-23	STANDARD
LABELING; Labeling	SUPPL	34	AP	1996-03-26	STANDARD
LABELING; Labeling	SUPPL	35	AP	1996-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1996-11-04	STANDARD
LABELING; Labeling	SUPPL	37	AP	2009-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1998-06-11	STANDARD
EFFICACY; Efficacy	SUPPL	39	AP	1998-10-29	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	1998-10-29	PRIORITY
LABELING; Labeling	SUPPL	41	AP	1998-10-30	STANDARD
LABELING; Labeling	SUPPL	43	AP	1999-04-02	STANDARD
LABELING; Labeling	SUPPL	44	AP	2009-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2000-04-24	STANDARD
EFFICACY; Efficacy	SUPPL	46	AP	2000-06-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2000-12-14	STANDARD
LABELING; Labeling	SUPPL	48	AP	2003-06-10	STANDARD
LABELING; Labeling	SUPPL	49	AP	2002-05-16	STANDARD
LABELING; Labeling	SUPPL	50	AP	2002-08-30	STANDARD
LABELING; Labeling	SUPPL	51	AP	2003-01-30	STANDARD
LABELING; Labeling	SUPPL	52	AP	2004-12-14	STANDARD
LABELING; Labeling	SUPPL	53	AP	2005-03-17	STANDARD
EFFICACY; Efficacy	SUPPL	54	AP	2006-03-09	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	21	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17970
            [companyName] => ASTRAZENECA
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088661.pdf"]
            [products] => [{"drugName":"NOLVADEX","activeIngredients":"TAMOXIFEN CITRATE","strength":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NOLVADEX","activeIngredients":"TAMOXIFEN CITRATE","strength":"EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/13\/2009","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/17970s37s44s49lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2009","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/17970s37s44s49lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2006","submission":"SUPPL-54","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/017970s054lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2005","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/17970s053lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2004","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17970s052lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2003","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/17970slr048_nolvadex_lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2003","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2003\\\/17-970S049FA_Nolvadex_prntlbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2002","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21109lbl,17970s50lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2002","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/17970s37s44s49lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2000","submission":"SUPPL-46","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/17970S46LBL.PDF\"}]","notes":""},{"actionDate":"10\/29\/1998","submission":"SUPPL-40","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/17970.pdf\"}]","notes":""},{"actionDate":"10\/29\/1998","submission":"SUPPL-39","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/17970.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NOLVADEX","submission":"TAMOXIFEN CITRATE","actionType":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NOLVADEX","submission":"TAMOXIFEN CITRATE","actionType":"EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-03-13
        )

)