Regulatory PathRegulatory requirements compared

Active substance

Glyceryl trinitrate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
GLYCERYL TRINITRATE 50MG-10ML I-V AMP5 mg/mlSolution for injection · Intravenous use5 AmpouleSAR 131.10Generic · PrescriptionHOSPIRA UK LIMITEDValid
NITRODERM TTS 5 PATCHES25 mgTransdermal patch · Transdermal use30 SachetSAR 58.30NCE · PrescriptionSandoz PharmaceuticalsValid
NITRODERM TTS 5 PATCHES25 mgTransdermal patch · Transdermal use10 SachetSAR 17.60NCE · PrescriptionSandoz PharmaceuticalsValid
NITRODERM TTS-10 SYSTEM50 mgTransdermal patch · Topical10 SachetSAR 33.75NCE · PrescriptionSandoz PharmaceuticalsValid
NITRODERM TTS-10 SYSTEM50 mgTransdermal patch · Topical30 SachetSAR 62.60NCE · PrescriptionSandoz PharmaceuticalsValid
Netrosan0.4 % (W/W)Rectal ointment · Topical1 TubeSAR 76.45Generic · PrescriptionSana pharmaceutical IndustryValid
Retrosin Ointment0.4 %Rectal ointment · Topical1 TubeSAR 91.40NCE · PrescriptionPHILADELPHIA PHARMACEUTICALSValid
GLYCERYL TRINITRATE 50MG-10ML I-V AMP5 mg/mlSolution for injection · Intravenous use5 AmpouleSAR 131.10Generic · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
NITRO-DUR15 mgTransdermal patch · Transdermal use10 BoxSAR 31.70NCE · PrescriptionSCHERING-PLOUGHWithdrawn by MAH · Not Marketed
NITRO-DUR10 mgTransdermal patch · Transdermal use10 BoxSAR 39.10NCE · PrescriptionSCHERING-PLOUGHWithdrawn by MAH · Not Marketed
NITRO-DUR5 mgTransdermal patch · Transdermal use10 BoxSAR 23.50NCE · PrescriptionSCHERING-PLOUGHWithdrawn by MAH · Not Marketed
NITROGLYCERINE INJ F.T.V.5 ML 25 MG5 mg/mlSolution · Intravenous use1 VialSAR 36.85NCE · PrescriptionHOSPIRA INCWithdrawn by MAH · Not Marketed
NITROGLYCERINE INJ F.T.V.50MG-10 ML5 mg/mlSolution · Intravenous use1 VialSAR 50.45NCE · PrescriptionHOSPIRA INCWithdrawn by MAH · Not Marketed
NITROSTAT 0.6 MG TAB0.6 mgTablet · Oral use100 BlisterSAR 5.70NCE · PrescriptionPARK-DAVISWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HYPERTENSION; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)

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

ProductStrengthForm · routeApplicantStatusFirst approved
NITROGLYCERIN2%ointment · transdermalFOUGERA PHARMS INCPrescription28 May 1981
NITROLINGUAL PUMPSPRAY0.4MG/SPRAYspray, metered · sublingualPOHL BOSKAMPPrescription31 Oct 1985
NITRO-DUR0.1MG/HR; 0.2MG/HR; 0.3MG/HR; 0.4MG/HR; 0.6MG/HR; 0.8MG/HRfilm, extended release · transdermalUSPHARMAPrescription10 Dec 1985
NITROGLYCERIN5MG/MLinjectable · injectionAM REGENTPrescription24 May 1988
NITROGLYCERIN IN DEXTROSE 5%10MG/100ML; 20MG/100ML; 40MG/100MLinjectable · injectionBAXTER HLTHCAREPrescription29 Dec 1989
NITROGLYCERIN0.6MG/HR; 0.4MG/HR; 0.2MG/HR; 0.1MG/HRfilm, extended release · transdermalMYLAN TECHNOLOGIESPrescription30 Aug 1996
NITROGLYCERIN0.2MG/HRfilm, extended release · transdermalZYDUS PHARMSPrescription30 Oct 1998
NITROGLYCERIN0.4MG/HR; 0.1MG/HRfilm, extended release · transdermalZYDUS PHARMSPrescription30 Oct 1998
NITROGLYCERIN0.6MG/HRfilm, extended release · transdermalZYDUS PHARMSPrescription30 Oct 1998
NITROSTAT0.3MG; 0.4MG; 0.6MGtablet · sublingualVIATRISPrescription1 May 2000
NITROMIST0.4MG/SPRAYaerosol, metered · sublingualEVUSPrescription2 Nov 2006
NITROGLYCERIN0.4MG/SPRAYspray, metered · sublingualPADAGIS ISRAELPrescription20 Sep 2013
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualDR REDDYSPrescription26 Aug 2016
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualGLENMARK SPECLTPrescription19 Sep 2017
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualNATCOPrescription30 Apr 2019
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualRUBICON RESEARCHPrescription3 May 2021
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualAUROBINDO PHARMAPrescription26 Oct 2023
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualMANKIND PHARMAPrescription5 Dec 2023
NITROGLYCERIN0.4%ointment · intra-analCOSETTE PHARMS NCPrescription16 Feb 2024
NITROGLYCERIN0.3MG; 0.4MG; 0.6MGtablet · sublingualPHARMOBEDIENTPrescription15 Oct 2024
NITROGLYCERIN0.4%ointment · intra-analTP ANDA HOLDINGSPrescription29 Nov 2024
NITROGLYCERIN0.4%ointment · intra-analENCUBEPrescription16 Dec 2024
NITROGLYCERIN2%ointment · transdermalENCUBEPrescription15 Apr 2025
NITROGLYCERIN0.4%ointment · intra-analAMVIKAPrescription18 Dec 2025
NITROGLYCERIN0.4%ointment · intra-analPADAGIS ISRAELPrescription6 Jul 2026

40 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MYLAN-NITRO PATCH 0.2024074420.2 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALMYLAN PHARMACEUTICALS ULC
MYLAN-NITRO PATCH 0.4024074500.4 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALMYLAN PHARMACEUTICALS ULC
MYLAN-NITRO PATCH 0.6024074690.6 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALMYLAN PHARMACEUTICALS ULC
MYLAN-NITRO PATCH 0.8024074770.8 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALMYLAN PHARMACEUTICALS ULC
NITRO-DUR 0.2019119100.2 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALUSPHARMA LTD
NITRO-DUR 0.4019119020.4 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALUSPHARMA LTD
NITRO-DUR 0.6019119290.6 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALUSPHARMA LTD
NITRO-DUR 0.8020112710.8 MG / HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALUSPHARMA LTD
NITROJECT0077886950 MG / 10 MLSOLUTION · INTRAVENOUSJUNO PHARMA CANADA INC.
NITROLINGUAL PUMPSPRAY022314410.4 MG / ACTMETERED-DOSE PUMP · SUBLINGUALG POHL-BOSKAMP GMBH & CO KG
NITROSTAT000376130.3 MGTABLET · SUBLINGUALBGP PHARMA ULC
NITROSTAT000376210.6 MGTABLET · SUBLINGUALBGP PHARMA ULC
RHO-NITRO PUMPSPRAY022389980.4 MG / ACTMETERED-DOSE PUMP · SUBLINGUALSANDOZ CANADA INCORPORATED
TRINIPATCH 0.2022307320.2 MG / HOURPATCH · TRANSDERMALKNIGHT THERAPEUTICS INC.
TRINIPATCH 0.4022307330.4 MG / HOURPATCH · TRANSDERMALKNIGHT THERAPEUTICS INC.
TRINIPATCH 0.6022307340.6 MG / HOURPATCH · TRANSDERMALKNIGHT THERAPEUTICS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNITRO-BID 2% OINTMENT$2.42188per GM23 Sep 2026
US NADACNITRO-BID 2% OINTMENT$1.23629per GM23 Sep 2026
US NADACNITRO-BID 2% OINTMENT$1.22466per GM23 Sep 2026
US NADACNITRO-DUR 0.3 MG/HR PATCH$50.49727per EA19 Aug 2026
US NADACNITROGLYCERIN 0.1 MG/HR PATCH$0.49331per EA23 Sep 2026
US NADACNITROGLYCERIN 0.2 MG/HR PATCH$0.59034per EA23 Sep 2026
US NADACNITROGLYCERIN 0.3 MG TABLET SL$0.06315per EA23 Sep 2026
US NADACNITROGLYCERIN 0.4 MG TABLET SL$0.12724per EA23 Sep 2026
US NADACNITROGLYCERIN 0.4 MG TABLET SL$0.07873per EA23 Sep 2026
US NADACNITROGLYCERIN 0.4 MG/HR PATCH$0.72064per EA23 Sep 2026
US NADACNITROGLYCERIN 0.4% OINTMENT$8.3149per GM23 Sep 2026
US NADACNITROGLYCERIN 0.6 MG TABLET SL$0.08428per EA23 Sep 2026
NHS Drug TariffGlyceryl trinitrate 0.4% rectal ointment£39.3030 gram1 Oct 2026
NHS Drug TariffGlyceryl trinitrate 10mg/24hours transdermal patches£14.0628 patch1 Oct 2026
NHS Drug TariffGlyceryl trinitrate 400micrograms/dose pump sublingual spray£2.7575 dose1 Oct 2026
NHS Drug TariffGlyceryl trinitrate 400micrograms/dose pump sublingual spray£3.41180 dose1 Oct 2026
NHS Drug TariffGlyceryl trinitrate 400micrograms/dose pump sublingual spray£3.78200 dose1 Oct 2026
NHS Drug TariffGlyceryl trinitrate 500microgram sublingual tablets£16.35100 tablet1 Oct 2026
NHS Drug TariffGlyceryl trinitrate 5mg/24hours transdermal patches£12.7728 patch1 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)

  • 12.1. Antianginal medicines · core
    Angina pectoris
    Oral > Solid: 500 µg sublingual tablet

Safety signals and safety-related labeling changes

All safety entries for glyceryl trinitrate →

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.