FDA.reportPublic FDA data

Application 017970

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOLVADEXTAMOXIFEN CITRATETABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002NOLVADEXTAMOXIFEN CITRATETABLET;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017970-001NOLVADEXTAMOXIFEN CITRATEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017970-002NOLVADEXTAMOXIFEN CITRATEEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-03-21

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017970-001NOLVADEXEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017970-002NOLVADEXEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-03-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017970-001NOLVADEXEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017970-002NOLVADEXEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-03-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017970-001NOLVADEXEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017970-002NOLVADEXEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-03-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017970-001NOLVADEXEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017970-002NOLVADEXEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-03-21a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamoxifen CitrateTAMOXIFEN CITRATENuCare Pharmaceuticals, Inc.509f8ba3-214d-aec8-e063-6294a90af4982026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEBryant Ranch Prepack8c0eb763-420a-4106-ba56-526b53a7f72b2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEA-S Medication Solutions8d731e7e-3b04-49a2-a0f6-3779422174cc2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEActavis Pharma, Inc.9b8a4211-120f-4981-ad69-928accb976372025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEMayne Pharma Commercial LLCc82205a3-ae0c-4ce5-b04b-9581cd8c70d42025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEA-S Medication Solutions716657e8-d809-4671-87bc-8d10ef69a0712025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEBryant Ranch Prepack9b4a8abc-6e56-40c5-a826-1d1f3c0786e12024-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATENuCare Pharmaceuticals,Inc.a5615dbb-3c5e-6ccc-e053-2995a90ab6982024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEDr. Reddy's Labratories Inc.c6c6a643-57d6-7ea5-7da0-e8a66802468a2024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEBryant Ranch Prepackfeb96056-79f5-4024-ab0e-fdbb8d4ab8622024-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEProficient Rx LPbb53eeb7-83fc-469e-b9e3-df5f27bfec7b2022-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
SOLTAMOXTAMOXIFEN CITRATEMayne Pharma1e6ff055-590c-41e6-9530-1fdf04cdbd022021-11-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEMylan Pharmaceuticals Inc.7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f02021-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TAMOXIFEN CITRATE
Tamoxifen CitrateTAMOXIFEN CITRATEAurobindo Pharma Limiteda596c715-8e30-43c1-aba3-4fe5de6729fa2020-08-14Boxed warning, Warnings, Adverse reactionsName 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
DocumentSubmission typeDate
53729SUPPL2018-04-18
43602ORIG2009-11-19
40766SUPPL2009-09-14
768SUPPL2006-03-23
33386SUPPL2006-03-14
33385SUPPL2005-03-23
767SUPPL2005-03-23
11105SUPPL2004-12-30
766SUPPL2004-12-30
33384SUPPL2004-06-10
13972SUPPL2004-06-10
20100SUPPL2003-07-05
20099SUPPL2003-07-05
11103SUPPL2003-06-22
764SUPPL2003-06-22
40769SUPPL2003-03-07
13971SUPPL2002-08-30
11104SUPPL2002-08-30
33383SUPPL2002-05-16
33381SUPPL2002-05-16
13968SUPPL2002-05-16
11101SUPPL2002-05-16
765SUPPL2002-05-16
763SUPPL2002-05-16
40768SUPPL2000-06-29
33382SUPPL2000-06-29
13970SUPPL2000-06-29
40767SUPPL1998-10-29
33380SUPPL1998-10-29
20098SUPPL1998-10-29
13969SUPPL1998-10-29
11102SUPPL1998-10-29
762SUPPL1998-10-29