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 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANASTROZOLEANASTROZOLEBryant Ranch Prepack1d1d5818-1594-4f54-90a9-ae9a9afcdc672026-08-20Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEBreckenridge Pharmaceutical, Inc.ca9d4aff-ffdf-4a46-ad20-e47e5886a19e2026-08-18Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEPD-Rx Pharmaceuticals, Inc.5d4f90d4-e535-4681-a863-3d774a2064e62026-08-07Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.54da5c12-cfaf-7a14-e063-6394a90a36352026-08-05Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEDirect_Rx58390d1f-7390-a21f-e063-6294a90a04792026-08-04Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.aabd8f88-2b52-4d43-8dc6-61605988c4dc2026-07-07Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEBryant Ranch Prepackf5b53383-0366-4ae2-9aa4-88b56c0bbd072026-06-18Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals,Inc.69be1c52-93db-e2c3-e053-2a91aa0af7742026-05-28Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEAvPAK94a46579-0d79-89c7-e053-2995a90a64672026-03-10Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ARIMIDEXANASTROZOLEANI Pharmaceuticals, Inc.acbfaaa9-503c-4691-9828-76a7146ed6de2026-03-02Warnings, Adverse reactionsName fallback
brand name: ARIMIDEX
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAsclemed USA, Inc.b964f555-25d2-47ad-8942-f195f062445c2026-02-14Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAccord Healthcare Inc.03586c40-eb32-45c5-beb7-6762a6b787902026-02-11Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAvKAREa0c2672b-e07b-4f6c-e053-2a95a90a2e5d2026-01-14Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEAvKAREf40b925f-9f43-321d-e053-2a95a90aca8b2026-01-13Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals, Inc.362034e9-2830-19a5-e063-6394a90a8dfb2025-12-09Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEChartwell RX, LLCda6ae05c-81e9-492a-a4c9-be3f1f367b592025-12-09Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAmerican Health Packagingdface914-5135-4136-82f4-75429b496a352025-08-29Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAurobindo Pharma Limited71f053c2-8d0d-41a1-8630-2d797eced7992025-05-19Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals,Inc.33f14d51-de4e-cbe4-e063-6294a90a964b2025-04-29Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEA-S Medication Solutions90d9dbb4-b1ba-431e-b588-1a1a04cf14442025-04-29Warnings, 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