FDA — authorised 31 March 2000
- Application: ANDA074278
- Marketing authorisation holder: HIKMA
- Local brand name: LEVORPHANOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LEVORPHANOL TARTRATE in United States
FDA authorised LEVORPHANOL TARTRATE on 31 March 2000 · 202 US adverse-event reports
Marketing authorisations
FDA — authorised 13 December 2018
- Application: ANDA211484
- Marketing authorisation holder: ACERTIS PHARMS
- Local brand name: LEVORPHANOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2019
- Application: ANDA212024
- Marketing authorisation holder: SPECGX LLC
- Local brand name: LEVORPHANOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2020
- Application: ANDA213479
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: LEVORPHANOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2021
- Application: ANDA213906
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: LEVORPHANOL TARTRATE
- Indication: TABLET — ORAL
- 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: 202
Most-reported reactions
- Product Dose Omission Issue — 35 reports (17.33%)
- Pain — 29 reports (14.36%)
- Drug Ineffective — 25 reports (12.38%)
- Nausea — 25 reports (12.38%)
- Product Dose Omission — 21 reports (10.4%)
- Headache — 17 reports (8.42%)
- Diarrhoea — 13 reports (6.44%)
- Hyperhidrosis — 13 reports (6.44%)
- Product Availability Issue — 12 reports (5.94%)
- Withdrawal Syndrome — 12 reports (5.94%)
LEVORPHANOL 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 LEVORPHANOL TARTRATE approved in United States?
Yes. FDA authorised it on 31 March 2000; FDA authorised it on 13 December 2018; FDA authorised it on 13 December 2019.
Who is the marketing authorisation holder for LEVORPHANOL TARTRATE in United States?
HIKMA holds the US marketing authorisation.