Regulatory PathRegulatory requirements compared

Active substance

Anastrozole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ANADEX 1MG F.C.TABLET1 mgFilm-coated tablet · Oral use28 BlisterSAR 120.00Generic · PrescriptionADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANYValid
ANASTROZOLE 1MG F.C.TABLET1 mgFilm-coated tablet · Oral use28 BlisterSAR 156.75Generic · PrescriptionLABORATORIOS CINFA SAValid
ARIMIDEX 1MG TAB1 mgFilm-coated tablet · Oral use28 BlisterSAR 184.45NCE · PrescriptionAstraZenecaValid
Anastrozole Pharmacare1 mgFilm-coated tablet · Oral use30 BlisterSAR 128.25Generic · PrescriptionPharmacare Premium LtdValid
TABIDEX 1 MG F. C. TABLET1 mgFilm-coated tablet · Oral use28 BlisterSAR 105.10Generic · PrescriptionAccord Healthcare LimitedValid
ANASTRALEX 1 MG FILM COATED TABLET1 mgTablet · Oral use30 BottleSAR 128.40Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Withdrawn by MAH · Not Marketed
DP-ANASTROZOLE 1 mg tablet1 mgFilm-coated tablet · Oral use30 BlisterSAR 62.55Generic · PrescriptionDOUGLAS MANUFACTURING LtdWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BREAST CANCER EARLY HORMONAL; BREAST CANCER MET.HORMONAL; ENDOMETRIOSIS; OVARIAN CANCER

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ARIMIDEX1MGtablet · oralANI PHARMSPrescription27 Dec 1995
ARIMIDEX1MGtablet · oralASTRAZENECAPrescription5 Dec 2008
ANASTROZOLE1MGtablet · oralTEVA PHARMSPrescription28 Jun 2010
ANASTROZOLE1MGtablet · oralZYDUS PHARMS USA INCPrescription28 Jun 2010
ANASTROZOLE1MGtablet · oralKENTONPrescription28 Jun 2010
ANASTROZOLE1MGtablet · oralNATCO PHARMA LTDPrescription28 Jun 2010
ANASTROZOLE1MGtablet · oralACCORD HLTHCAREPrescription28 Jun 2010
ANASTROZOLE1MGtablet · oralCIPLAPrescription28 Jun 2010
ANASTROZOLE1MGtablet · oralBEIJING YILINGPrescription9 Nov 2018
ANASTROZOLE1MGtablet · oralEUGIA PHARMAPrescription24 Jul 2020
ANASTROZOLE1MGtablet · oralHIKMA PHARMSDiscontinued28 Jun 2010
ANASTROZOLE1MGtablet · oralWATSON LABS TEVADiscontinued28 Jun 2010
ANASTROZOLE1MGtablet · oralSANDOZDiscontinued28 Jun 2010
ANASTROZOLE1MGtablet · oralFRESENIUS KABI USADiscontinued28 Jun 2010
ANASTROZOLE1MGtablet · oralCHARTWELL RXDiscontinued28 Jun 2010
ANASTROZOLE1MGtablet · oralPHARMOBEDIENTDiscontinued28 Jun 2010
ANASTROZOLE1MGtablet · oralCHARTWELL MOLECULARDiscontinued5 Jan 2011
ANASTROZOLE1MGtablet · oralSUN PHARM INDS LTDDiscontinued15 Jul 2011
ANASTROZOLE1MGtablet · oralAPOTEX INCDiscontinued11 May 2012
ANASTROZOLE1MGtablet · oralIMPAX LABS INCDiscontinued31 May 2012
ANASTROZOLE1MGtablet · oralSYNTHON PHARMSDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-ANASTROZOLE023512181 MGTABLET · ORALACCORD HEALTHCARE INC
AG-ANASTROZOLE TABLETS025536861 MGTABLET · ORALANGITA PHARMA INC.
ANASTROZOLE024427361 MGTABLET · ORALSANIS HEALTH INC
ANASTROZOLE025299041 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
APO-ANASTROZOLE023744201 MGTABLET · ORALAPOTEX INC
ARIMIDEX022241351 MGTABLET · ORALASTRAZENECA CANADA INC
BIO-ANASTROZOLE023924881 MGTABLET · ORALBIOMED PHARMA
JAMP ANASTROZOLE TABLETS025405841 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP-ANASTROZOLE023390801 MGTABLET · ORALJAMP PHARMA CORPORATION
MAR-ANASTROZOLE023795621 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-ANASTROZOLE023935731 MGTABLET · ORALMINT PHARMACEUTICALS INC
NAT-ANASTROZOLE024178551 MGTABLET · ORALNATCO PHARMA (CANADA) INC
PMS-ANASTROZOLE023207381 MGTABLET · ORALPHARMASCIENCE INC
PRO-ANASTROZOLE023956491 MGTABLET · ORALPRO DOC LIMITEE
RIVA-ANASTROZOLE023922591 MGTABLET · ORALLABORATOIRE RIVA INC.
SANDOZ ANASTROZOLE023384671 MGTABLET · ORALSANDOZ CANADA INCORPORATED
TARO-ANASTROZOLE023656501 MGTABLET · ORALTARO PHARMACEUTICALS INC
TEVA-ANASTROZOLE023948981 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACANASTROZOLE 1 MG TABLET$0.14163per EA23 Sep 2026
US NADACARIMIDEX 1 MG TABLET$52.86163per EA23 Sep 2026
NHS Drug TariffAnastrozole 1mg tablets£1.0628 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.4. Hormones and antihormones · complementary
    Malignant neoplasms of breast; Other specified malignant neoplasms of breast
    Oral > Solid: 1 mg tablet
  • 22.2. Ovulation inducers · complementary
    Therapeutic equivalent to letrozole for Female infertility without specification whether primary or secondary

Safety signals and safety-related labeling changes

All safety entries for anastrozole →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.