Application 017970

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOLVADEX	TAMOXIFEN CITRATE	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	NOLVADEX	TAMOXIFEN CITRATE	TABLET;ORAL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017970-001	NOLVADEX	TAMOXIFEN CITRATE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N017970-002	NOLVADEX	TAMOXIFEN CITRATE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1994-03-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1994-03-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017970-001	NOLVADEX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017970-002	NOLVADEX	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1994-03-21	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals, Inc.	509f8ba3-214d-aec8-e063-6294a90af498	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	8c0eb763-420a-4106-ba56-526b53a7f72b	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	8d731e7e-3b04-49a2-a0f6-3779422174cc	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Actavis Pharma, Inc.	9b8a4211-120f-4981-ad69-928accb97637	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Mayne Pharma Commercial LLC	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	716657e8-d809-4671-87bc-8d10ef69a071	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	9b4a8abc-6e56-40c5-a826-1d1f3c0786e1	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals,Inc.	a5615dbb-3c5e-6ccc-e053-2995a90ab698	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Dr. Reddy's Labratories Inc.	c6c6a643-57d6-7ea5-7da0-e8a66802468a	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	feb96056-79f5-4024-ab0e-fdbb8d4ab862	2024-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Proficient Rx LP	bb53eeb7-83fc-469e-b9e3-df5f27bfec7b	2022-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
SOLTAMOX	TAMOXIFEN CITRATE	Mayne Pharma	1e6ff055-590c-41e6-9530-1fdf04cdbd02	2021-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Mylan Pharmaceuticals Inc.	7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0	2021-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE
Tamoxifen Citrate	TAMOXIFEN CITRATE	Aurobindo Pharma Limited	a596c715-8e30-43c1-aba3-4fe5de6729fa	2020-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAMOXIFEN CITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53729	SUPPL	2018-04-18
43602	ORIG	2009-11-19
40766	SUPPL	2009-09-14
768	SUPPL	2006-03-23
33386	SUPPL	2006-03-14
33385	SUPPL	2005-03-23
767	SUPPL	2005-03-23
11105	SUPPL	2004-12-30
766	SUPPL	2004-12-30
33384	SUPPL	2004-06-10
13972	SUPPL	2004-06-10
20100	SUPPL	2003-07-05
20099	SUPPL	2003-07-05
11103	SUPPL	2003-06-22
764	SUPPL	2003-06-22
40769	SUPPL	2003-03-07
13971	SUPPL	2002-08-30
11104	SUPPL	2002-08-30
33383	SUPPL	2002-05-16
33381	SUPPL	2002-05-16
13968	SUPPL	2002-05-16
11101	SUPPL	2002-05-16
765	SUPPL	2002-05-16
763	SUPPL	2002-05-16
40768	SUPPL	2000-06-29
33382	SUPPL	2000-06-29
13970	SUPPL	2000-06-29
40767	SUPPL	1998-10-29
33380	SUPPL	1998-10-29
20098	SUPPL	1998-10-29
13969	SUPPL	1998-10-29
11102	SUPPL	1998-10-29
762	SUPPL	1998-10-29