Regulatory PathRegulatory requirements compared

Active substances

Ethinylestradiol + Norethisterone

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRI-NORINYL 28-DAY0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MGtablet · oral-28DR REDDYS LABS SAPrescription11 Apr 1984
NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGtablet · oral-28WATSON LABS TEVAPrescription29 Jan 1987
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)0.035MG,0.035MG;0.5MG,1MGtablet · oral-28WATSON LABS TEVAPrescription1 Apr 1988
NORTREL 1/35-210.035MG;1MGtablet · oral-21BARRPrescription28 Feb 1992
NORTREL 0.5/35-280.035MG;0.5MGtablet · oral-28BARR LABSPrescription28 Feb 1992
NORTREL 1/35-280.035MG;1MGtablet · oral-28BARR LABSPrescription28 Feb 1992
FEMHRT0.005MG;1MGtablet · oralWARNER CHILCOTTPrescription15 Oct 1999
NORTREL 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGtablet · oral-21BARRPrescription30 Aug 2002
NORTREL 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGtablet · oral-28BARRPrescription30 Aug 2002
JUNEL 1/200.02MG;1MGtablet · oral-21BARR LABSPrescription30 May 2003
JUNEL 1.5/300.03MG;1.5MGtablet · oral-21BARRPrescription30 May 2003
JUNEL FE 1.5/300.03MG;1.5MGtablet · oral-28BARRPrescription18 Sep 2003
JUNEL FE 1/200.02MG;1MGtablet · oral-28BARRPrescription18 Sep 2003
BALZIVA-280.035MG;0.4MGtablet · oral-28BARRPrescription22 Apr 2004
ARANELLE0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MGtablet · oral-28BARRPrescription29 Sep 2004
TRI-LEGEST FE0.02MG,0.03MG,0.035MG;1MG,1MG,1MGtablet · oral-28BARRPrescription26 Oct 2007
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGtablet · oralBARR LABS INCPrescription6 Nov 2009
NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;0.4MGtablet · oral-28WATSON LABSPrescription4 Feb 2010
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.035MG;0.4MGtablet · oralBARRPrescription5 Aug 2010
LO LOESTRIN FE0.01MG,0.01MG;1MG,N/Atablet · oralAPILPrescription21 Oct 2010
BRIELLYN0.035MG;0.4MGtablet · oral-28GLENMARK PHARMS LTDPrescription22 Mar 2011
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.035MG;0.4MGtablet · oralAMNEAL PHARMSPrescription26 Sep 2011
DASETTA 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGtablet · oral-28NOVAST LABS LTDPrescription22 Dec 2011
PHILITH0.035MG;0.4MGtablet · oral-28NOVAST LABS LTDPrescription22 Dec 2011
DASETTA 1/350.035MG;1MGtablet · oral-28NOVAST LABS LTDPrescription22 Dec 2011

139 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BREVICON 0.5/35 TABLETS (21-DAY PACK)021870860.035 MG; 0.5 MGTABLET · ORALPFIZER CANADA ULC
BREVICON 0.5/35 TABLETS (28-DAY PACK)02187094.5 MG; .035 MGTABLET · ORALPFIZER CANADA ULC
BREVICON 1/35 TABLETS (21-DAY PACK)021890541 MG; 0.035 MGTABLET · ORALPFIZER CANADA ULC
BREVICON 1/35 TABLETS (28-DAY PACK)021890620.035 MG; 1 MGTABLET · ORALPFIZER CANADA ULC
ELFY025534811 MG; 10 MCGTABLET · ORALAPOTEX INC
LOLO0241745610 MCG; 1 MGTABLET · ORALABBVIE CORPORATION
SELECT 1/35 (21-DAY)021975020.035 MG; 1.0 MGTABLET · ORALPFIZER CANADA ULC
SELECT 1/35 (28-DAY)021992970.035 MG; 1.0 MGTABLET · ORALPFIZER CANADA ULC
SYNPHASIC 21 TABLETS021871080.035 MG; 1.0 MG; 0.5 MGTABLET · ORALPFIZER CANADA ULC
SYNPHASIC 28 TABLETS021871160.035 MG; 1.0 MG; 0.5 MGTABLET · ORALPFIZER CANADA ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACARANELLE 28 TABLET$0.63013per EA23 Sep 2026
US NADACBRIELLYN 0.4 MG-0.035 MG TAB$0.32955per EA23 Sep 2026
US NADACFEMLYV 1 MG-0.02 MG ODT$7.04096per EA1 Sep 2026
US NADACFINZALA 1-0.02(24)-75 CHEW TAB$0.3041per EA23 Sep 2026
US NADACFYAVOLV 0.5 MG-2.5 MCG TABLET$0.9127per EA23 Sep 2026
US NADACFYAVOLV 1 MG-5 MCG TABLET$0.57994per EA23 Sep 2026
US NADACGEMMILY 1 MG-20 MCG CAPSULE$0.96176per EA23 Sep 2026
US NADACKAITLIB FE 0.8-0.025 MG CHEW TB$1.40353per EA23 Sep 2026
US NADACLO LOESTRIN FE 1-10 TABLET$6.76607per EA23 Sep 2026
US NADACPHILITH 0.4-0.035 MG TABLET$0.32955per EA23 Sep 2026
US NADACTAYTULLA 1 MG-20 MCG CAPSULE$8.97473per EA23 Sep 2026
US NADACTRI-LEGEST FE-28 DAY TABLET$0.7459per EA23 Sep 2026
NHS Drug TariffEthinylestradiol 35microgram / Norethisterone 1mg tablets£2.2863 tablet1 Oct 2026
NHS Drug TariffEthinylestradiol 35microgram / Norethisterone 500microgram tablets£1.9963 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)

  • 22.1.1. Oral hormonal contraceptives · core
    Contact with health services for contraceptive management
    Oral > Solid: 35 µg + 1 mg

Components

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.