FDA — authorised 22 August 1978
- Application: NDA017857
- Marketing authorisation holder: APOTHECON
- Local brand name: STADOL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BUTORPHANOL TARTRATE in United States
FDA authorised BUTORPHANOL TARTRATE on 22 August 1978 · 297 US adverse-event reports
Marketing authorisations
FDA — authorised 12 December 1991
- Application: NDA019890
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: STADOL
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 22 January 1997
- Application: ANDA074620
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUTORPHANOL TARTRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 January 1997
- Application: ANDA074626
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUTORPHANOL TARTRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 August 1998
- Application: ANDA075045
- Marketing authorisation holder: HIKMA
- Local brand name: BUTORPHANOL TARTRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 August 1998
- Application: ANDA075046
- Marketing authorisation holder: HIKMA
- Local brand name: BUTORPHANOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 1998
- Application: ANDA075170
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUTORPHANOL TARTRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 November 1999
- Application: ANDA075342
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUTORPHANOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 March 2000
- Application: ANDA075559
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUTORPHANOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 August 2001
- Application: ANDA075759
- Marketing authorisation holder: RISING
- Local brand name: BUTORPHANOL TARTRATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 12 March 2002
- Application: ANDA075824
- Marketing authorisation holder: HIKMA
- Local brand name: BUTORPHANOL TARTRATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 4 December 2002
- Application: ANDA075499
- Marketing authorisation holder: APOTEX
- Local brand name: BUTORPHANOL TARTRATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 29 April 2009
- Application: ANDA078247
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: BUTORPHANOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 May 2009
- Application: ANDA078400
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: BUTORPHANOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 297
Most-reported reactions
- Drug Ineffective — 68 reports (22.9%)
- Drug Hypersensitivity — 48 reports (16.16%)
- Product Dose Omission Issue — 37 reports (12.46%)
- Nausea — 34 reports (11.45%)
- Headache — 24 reports (8.08%)
- Migraine — 19 reports (6.4%)
- Product Quality Issue — 18 reports (6.06%)
- Pain — 17 reports (5.72%)
- Pruritus — 16 reports (5.39%)
- Vomiting — 16 reports (5.39%)
BUTORPHANOL TARTRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BUTORPHANOL TARTRATE approved in United States?
Yes. FDA authorised it on 22 August 1978; FDA authorised it on 12 December 1991; FDA authorised it on 22 January 1997.
Who is the marketing authorisation holder for BUTORPHANOL TARTRATE in United States?
APOTHECON holds the US marketing authorisation.