Regulatory PathRegulatory requirements compared

Active substance

Progesterone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CYCLOGEST 200MG PESSARIES200 mgPessary · Vaginal use15 BlisterSAR 66.20NCE · PrescriptionL.D Collins & CO LtdValid
CYCLOGEST 400MG PESSARIES400 mgPessary · Vaginal use15 BlisterSAR 87.65NCE · PrescriptionL.D Collins & CO LtdValid
Crinone8 %Vaginal gel · Vaginal use15 Vaginal Sponge ApplicatorSAR 185.05NCE · PrescriptionMERCK SERONO EUROPE LTDValid
ENDOMETRIN 100 mg vafinal tablet100 mgVaginal tablet · Vaginal use21 BlisterSAR 84.20NCE · PrescriptionFERRINGValid
Lutigest200 mgCapsule, soft · Oral use , Vaginal use15 BlisterSAR 59.50Generic · PrescriptionExeltis Healthcare S.LValid
PROLUTEX25 mgSolution for injection · intramuscular, subcutaneous7 VialSAR 213.00NCE · PrescriptionIBSA Istitut Biochimique SAValid
Utrogestan100 mgCapsule, soft · Oral use , Vaginal use30 BlisterSAR 67.60Generic · PrescriptionLaboratoires Besins InternationalValid
Utrogestan200 mgCapsule, soft · Oral use , Vaginal use15 BlisterSAR 67.60Generic · PrescriptionLaboratoires Besins InternationalValid
Indications — CHI Daman Drug Formulary

MATERNAL AND CHILD HEALTHCARE- PREVENTION OF PRETERM LABOR AND BIRTH

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

ProductStrengthForm · routeApplicantStatusFirst approved
CRINONE8%gel · vaginalWATSON LABS INCPrescription13 May 1997
CRINONE8%gel · vaginalABBVIEPrescription31 Jul 1997
PROMETRIUM100MG; 200MGcapsule · oralACERTIS PHARMSPrescription14 May 1998
PROMETRIUM100MG; 200MG; 300MGcapsule · oralVIRTUS PHARMSPrescription16 Dec 1998
PROGESTERONE50MG/MLinjectable · injectionFRESENIUS KABI USAPrescription25 Apr 2001
ENDOMETRIN100MGinsert · vaginalFERRINGPrescription21 Jun 2007
PROGESTERONE50MG/MLinjectable · injectionHIKMA FARMACEUTICAPrescription28 Oct 2010
PROGESTERONE100MG; 200MGcapsule · oralSOFGEN PHARMSPrescription28 Sep 2012
PROGESTERONE100MG; 200MGcapsule · oralBIONPHARMAPrescription16 Aug 2013
PROGESTERONE100MG; 200MGcapsule · oralDR REDDYSPrescription28 Feb 2017
PROGESTERONE100MG; 200MGcapsule · oralAMNEAL PHARMS NYPrescription7 Sep 2017
PROGESTERONE100MG; 200MGcapsule · oralXIROMEDPrescription20 Oct 2017
PROGESTERONE100MG; 200MGcapsule · oralEUGIA PHARMAPrescription26 Oct 2018
PROGESTERONE50MG/MLinjectable · injectionEUGIA PHARMAPrescription6 Dec 2018
PROGESTERONE50MG/MLinjectable · injectionXIROMEDPrescription5 Jan 2022
PROGESTERONE50MG/MLinjectable · injectionACCORD HLTHCAREPrescription21 Nov 2023
PROGESTERONE100MGinsert · vaginalXIROMEDPrescription19 Sep 2025
PROGESTERONE100MGinsert · vaginalGLENMARK PHARMSPrescription8 Apr 2026
PROGESTERONE50MG/ML; 25MG/MLinjectable · injectionLILLYDiscontinued1 Nov 1974
PROGESTASERT38MGinsert, extended release · intrauterineALZADiscontinued4 Feb 1976
PROGESTERONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionACTAVIS LABS UT INCDiscontinued11 May 1978
CRINONE4%gel · vaginalABBVIEDiscontinued31 Jul 1997
PROMETRIUM300MGcapsule · oralACERTIS PHARMSDiscontinued14 May 1998
PROGESTERONE50MG/MLinjectable · injectionAM REGENTDiscontinued22 Jun 2009
PROGESTERONE100MG; 200MGcapsule · oralTEVA PHARMSDiscontinued29 Feb 2012

1 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-PROGESTERONE02549158100 MGCAPSULE · ORALACCORD HEALTHCARE INC
ACT PROGESTERONE INJECTION0244682050 MG / MLSOLUTION · INTRAMUSCULARTEVA CANADA LIMITED
AURO-PROGESTERONE02493578100 MGCAPSULE · ORALAURO PHARMA INC
CRINONE022410138 %GEL · VAGINALEMD SERONO, A DIVISION OF EMD INC., CANADA
ENDOMETRIN02334992100 MGVAGINAL TABLET (EFFERVESCENT) · VAGINALFERRING INC
M-PROGESTERONE02551268100 MGCAPSULE · ORALMANTRA PHARMA INC
PMS-PROGESTERONE02476576100 MGCAPSULE · ORALPHARMASCIENCE INC
PROGESTERONE02516187100 MGCAPSULE · ORALSANIS HEALTH INC
PROGESTERONE INJECTION, USP0253182850 MG / MLSOLUTION · INTRAMUSCULARHIKMA CANADA LIMITED
PROMETRIUM02166704100 MGCAPSULE · ORALORGANON CANADA INC.
REDDY-PROGESTERONE02463113100 MGCAPSULE · ORALDR. REDDY'S LABORATORIES INC
TEVA-PROGESTERONE02439913100 MGCAPSULE · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCRINONE 4% GEL$16.84389per GM2 Jan 2026
US NADACCRINONE 8% GEL$27.97261per GM23 Sep 2026
US NADACENDOMETRIN 100 MG VAG INSERT$15.15184per EA23 Sep 2026
US NADACPROGESTERONE 100 MG CAPSULE$0.22903per EA23 Sep 2026
US NADACPROGESTERONE 100 MG VAG INSERT$10.87559per EA23 Sep 2026
US NADACPROGESTERONE 200 MG CAPSULE$0.40405per EA23 Sep 2026
US NADACPROGESTERONE 500 MG/10 ML VIAL$1.36055per ML23 Sep 2026
US NADACPROMETRIUM 100 MG CAPSULE$15.90949per EA23 Sep 2026
US NADACPROMETRIUM 200 MG CAPSULE$30.39475per EA23 Sep 2026
NHS Drug TariffProgesterone 100mg pessaries£19.5021 pessary1 Oct 2026
NHS Drug TariffProgesterone 200mg pessaries£8.9515 pessary1 Oct 2026
NHS Drug TariffProgesterone 25mg/1.112ml solution for injection vials£56.007 vial1 Oct 2026
NHS Drug TariffProgesterone 400mg pessaries£12.9615 pessary1 Oct 2026
NHS Drug TariffProgesterone 8% vaginal gel 1.125g applicators£30.8315 unit dose1 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.

Safety signals and safety-related labeling changes

All safety entries for progesterone →

Combinations containing Progesterone

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.