FDA.reportPublic FDA data

Application 022214

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIMIDEXANASTROZOLETABLET; ORAL1MGYesNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.e3b5fc92-9189-6944-e053-2a95a90a1c9f2025-04-03Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.b023a9f2-1a99-4b40-a953-edac7e3a79bf2025-02-19Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEBluePoint Laboratories3cd04ed6-7c5a-4c4a-9955-ee40839dfea02025-02-10Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEDirect_Rxf37db328-bb81-9df9-e053-2a95a90a6f432025-01-22Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLETeva Pharmaceuticals USA, Inc.c58c7013-50a0-4734-8a78-38ff20a3e7eb2025-01-14Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEZydus Pharmaceuticals USA Inc.ca16f8de-d9a5-4c6c-957b-ae28497b67ac2025-01-03Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.5a2d5052-95ce-d103-e053-2991aa0aa4be2024-12-26Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEZydus Lifesciences Limited965c4cb1-f6b8-47ac-bf13-c36639aa908f2024-11-25Name fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEBryant Ranch Prepack19251d0b-279a-49f5-99b2-0e74d7cca4792024-08-22Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.a0acddf1-a973-bf37-e053-2995a90a0bd52024-06-20Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEA-S Medication Solutions03fb3108-1856-466d-bf88-0eac961395512024-06-05Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.ef6c9f7c-a1b0-3fee-e053-2995a90ab2c42024-04-05Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEProficient Rx LPc7a36fd8-530e-4c63-97d5-0f80fab5880e2023-05-01Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLENatco Pharma Limiteddf55dc4c-9a53-4a37-a90f-c4e88d458b892020-10-19Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21961ORIG2010-03-04
29415ORIG2008-12-11
58102ORIG1900-01-01
53178ORIG1900-01-01
53177ORIG1900-01-01
53176ORIG1900-01-01