Regulatory PathRegulatory requirements compared

Active substance

Butorphanol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/ML; 2MG/MLinjectable · injectionHOSPIRAPrescription23 Jan 1997
BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/ML; 2MG/MLinjectable · injectionHIKMA PHARMSPrescription12 Aug 1998
BUTORPHANOL TARTRATE2MG/MLinjectable · injectionHIKMA PHARMSPrescription12 Aug 1998
BUTORPHANOL TARTRATE1MG/SPRAYspray, metered · nasalHIKMA PHARMSPrescription12 Mar 2002
BUTORPHANOL TARTRATE1MG/SPRAYspray, metered · nasalAPOTEXPrescription4 Dec 2002
BUTORPHANOL TARTRATE1MG/ML; 2MG/MLinjectable · injectionHIKMA FARMACEUTICAPrescription1 May 2009
STADOL PRESERVATIVE FREE1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionAPOTHECONDiscontinued22 Aug 1978
STADOL2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionAPOTHECONDiscontinued22 Aug 1978
STADOL1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**spray, metered · nasalBRISTOL MYERS SQUIBBDiscontinued12 Dec 1991
BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/ML; 2MG/MLinjectable · injectionHOSPIRADiscontinued22 Jan 1997
BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/ML; 2MG/MLinjectable · injectionHOSPIRADiscontinued28 Sep 1998
BUTORPHANOL TARTRATE1MG/ML; 2MG/MLinjectable · injectionHOSPIRADiscontinued4 Nov 1999
BUTORPHANOL TARTRATE1MG/ML; 2MG/MLinjectable · injectionHOSPIRADiscontinued20 Mar 2000
BUTORPHANOL TARTRATE1MG/SPRAYspray, metered · nasalRISINGDiscontinued8 Aug 2001
BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/ML; 2MG/MLinjectable · injectionBAXTER HLTHCARE CORPDiscontinued23 Oct 2001
BUTORPHANOL TARTRATE2MG/MLinjectable · injectionBAXTER HLTHCARE CORPDiscontinued23 Oct 2001
BUTORPHANOL TARTRATE2MG/MLinjectable · injectionHIKMA FARMACEUTICADiscontinued29 Apr 2009

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BUTORPHANOL NASAL SPRAY0224250410 MG / MLSOLUTION · NASALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBUTORPHANOL 10 MG/ML SPRAY$15.45983per ML23 Sep 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.

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.