Regulatory PathRegulatory requirements compared

Active substance

Ipratropium

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ATROSOL 250 mcg/2 ml nebuliser solution125 µ/mlNebuliser solution · Inhalation use21 AmpouleSAR 27.55Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
ATROSOL 250 mcg/ml nebuliser solution250 µ/mlNebuliser solution · Inhalation use21 VialSAR 41.20Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
ATROVENT 250MCG-2ML UDV (SOLUTION FOR INHALATION)0.125 mg/mlinhalation solution · Inhalation use20 VialSAR 27.60NCE · PrescriptionBOEHRINGER INGELHEIMValid
ATROVENT 500MCG-2ML UDV (SOLUTION FOR INHALATION)0.25 mg/mlNebuliser solution · Inhalation use20 VialSAR 42.15NCE · PrescriptionBOEHRINGER INGELHEIMValid
ATROPULM 250MCG-ML SOLUTION FOR INHALATION0.25 mg/mlNebuliser solution · Inhalation use1 BottleSAR 10.00Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
ATROPULM 500MCG-2ML SOLUTION FOR INHALATION0.5 mg/mlNebuliser solution · Inhalation use10 AmpouleSAR 21.80Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
ATROVENT 0.02MG-METERED DOSE INHALER0.02 mgPowder · Inhalation use1 InhalerSAR 48.80NCE · PrescriptionBOEHRINGER INGELHEIMWithdrawn by MAH · Not Marketed
ATROVENT 250MCG-2ML UDV (SOLUTION FOR INHALATION)0.125 mg/mlNebuliser solution · Inhalation use20 VialSAR 33.75NCE · PrescriptionBOEHRINGER INGELHEIMWithdrawn by MAH · Not Marketed
ATROVENT 500MCG-2ML UDV (SOLUTION FOR INHALATION)0.25 mg/mlNebuliser solution · Inhalation use20 VialSAR 51.50NCE · PrescriptionBOEHRINGER INGELHEIMWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS)-LONG-TERM ORAL ANTIBIOTIC TREATMENT; ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); SICKLE CELL DISEASE - ACS MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
IPRATROPIUM BROMIDE0.02%solution · inhalationRITEDOSE CORPPrescription26 Jan 2001
IPRATROPIUM BROMIDE0.02%solution · inhalationNEPHRONPrescription27 Sep 2001
IPRATROPIUM BROMIDE0.021MG/SPRAYspray, metered · nasalBAUSCHPrescription31 Mar 2003
IPRATROPIUM BROMIDE0.042MG/SPRAYspray, metered · nasalBAUSCHPrescription31 Mar 2003
IPRATROPIUM BROMIDE0.042MG/SPRAYspray, metered · nasalAPOTEX INCPrescription18 Apr 2003
IPRATROPIUM BROMIDE0.021MG/SPRAYspray, metered · nasalAPOTEX INCPrescription18 Apr 2003
IPRATROPIUM BROMIDE0.042MG/SPRAYspray, metered · nasalHIKMA PHARMSPrescription5 Nov 2003
IPRATROPIUM BROMIDE0.021MG/SPRAYspray, metered · nasalHIKMA PHARMSPrescription5 Nov 2003
ATROVENT HFA0.021MG/INHaerosol, metered · inhalationBOEHRINGER INGELHEIMPrescription17 Nov 2004
IPRATROPIUM BROMIDE0.02%solution · inhalationLUOXIN AUROVITASPrescription27 Oct 2016
IPRATROPIUM BROMIDE0.021MG/SPRAYspray, metered · nasalAMNEALPrescription16 Aug 2022
IPRATROPIUM BROMIDE0.042MG/SPRAYspray, metered · nasalAMNEALPrescription16 Aug 2022
IPRATROPIUM BROMIDE0.042MG/SPRAYspray, metered · nasalRUBICON RESEARCHPrescription15 Nov 2024
IPRATROPIUM BROMIDE0.021MG/SPRAYspray, metered · nasalRUBICON RESEARCHPrescription14 Jan 2025
IPRATROPIUM BROMIDE0.042MG/SPRAYspray, metered · nasalLUPINPrescription27 Jan 2025
IPRATROPIUM BROMIDE0.021MG/SPRAYspray, metered · nasalLUPINPrescription7 Feb 2025
IPRATROPIUM BROMIDE0.021MG/INHaerosol, metered · inhalationARMSTRONG PHARMSPrescription23 Feb 2026
ATROVENT0.018MG/INHaerosol, metered · inhalationBOEHRINGER INGELHEIMDiscontinued29 Dec 1986
ATROVENT0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · inhalationBOEHRINGER INGELHEIMDiscontinued29 Sep 1993
ATROVENT0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**spray, metered · nasalBOEHRINGER INGELHEIMDiscontinued20 Oct 1995
ATROVENT0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**spray, metered · nasalBOEHRINGER INGELHEIMDiscontinued20 Oct 1995
IPRATROPIUM BROMIDE0.02%solution · inhalationPHARMOBEDIENTDiscontinued10 Jan 1997
IPRATROPIUM BROMIDE0.02%solution · inhalationACTAVIS MID ATLANTICDiscontinued22 Apr 1999
IPRATROPIUM BROMIDE0.02%solution · inhalationTEVA PHARMS USADiscontinued7 Feb 2000
IPRATROPIUM BROMIDE0.02%solution · inhalationZENNOVADiscontinued19 Jan 2001

8 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AA-IPRAVENT02126222250 MCG / MLSOLUTION · INHALATIONAA PHARMA INC
ATROVENT HFA0224768620 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONBOEHRINGER INGELHEIM (CANADA) LTD LTEE
IPRAVENT0224608442 MCG / ACTSOLUTION · NASALAA PHARMA INC
JAMP IPRATROPIUM HFA0254258720 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONJAMP PHARMA CORPORATION
PMS-IPRATROPIUM02231135125 MCG / MLSOLUTION · INHALATIONPHARMASCIENCE INC
PMS-IPRATROPIUM02231244250 MCG / MLSOLUTION · INHALATIONPHARMASCIENCE INC
PMS-IPRATROPIUM02231245250 MCG / MLSOLUTION · INHALATIONPHARMASCIENCE INC
PMS-IPRATROPIUM0223962721 MCG / ACTSOLUTION · NASALPHARMASCIENCE INC
TEVA-IPRATROPIUM STERINEBS02216221250 MCG / MLSOLUTION · INHALATIONTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACATROVENT 17 MCG HFA INHALER$22.76435per GM23 Sep 2026
US NADACIPRATROPIUM 0.03% SPRAY$0.36783per ML23 Sep 2026
US NADACIPRATROPIUM 0.06% SPRAY$0.77751per ML23 Sep 2026
US NADACIPRATROPIUM BR 0.02% SOLN$0.10402per ML23 Sep 2026
US NADACIPRATROPIUM BR 0.02% SOLN$0.1122per ML23 Sep 2026
US NADACIPRATROPIUM BR 0.02% SOLN$0.1099per ML23 Sep 2026
US NADACIPRATROPIUM BR 17 MCG HFA INH$22.10952per GM23 Sep 2026
NHS Drug TariffIpratropium bromide 20micrograms/dose inhaler CFC free£5.56200 dose1 Oct 2026
NHS Drug TariffIpratropium bromide 21micrograms/dose nasal spray£8.72240 dose1 Oct 2026
NHS Drug TariffIpratropium bromide 250micrograms/1ml nebuliser liquid unit dose vials£10.0520 unit dose1 Oct 2026
NHS Drug TariffIpratropium bromide 500micrograms/2ml nebuliser liquid unit dose vials£7.0320 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.

WHO WHO Model List of Essential Medicines (2025)

  • 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
    Chronic obstructive pulmonary disease; Asthma
    Respiratory > Inhalation > solution: 20 µg per actuation in pressurized metered dose inhaler

Safety signals and safety-related labeling changes

All safety entries for ipratropium →

Combinations containing Ipratropium

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.