FDA — authorised 25 May 2001
- Application: NDA021301
- Marketing authorisation holder: KING PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Levoxyl in United States
FDA authorised Levoxyl on 25 May 2001 · 9,582 US adverse-event reports
Marketing authorisations
FDA — authorised 26 March 2009
- Application: NDA021292
- Marketing authorisation holder: EMD SERONO INC
- Indication: Labeling
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA208749
- Marketing authorisation holder: MAIA PHARMS INC
- Status: approved
FDA — authorised 29 April 2022
- Application: NDA215809
- Marketing authorisation holder: MYLAN
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 24 March 2023
- Application: ANDA217066
- Marketing authorisation holder: ZYDUS PHARMS
- 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: 9,582
Most-reported reactions
- Drug Ineffective — 1,323 reports (13.81%)
- Fatigue — 1,280 reports (13.36%)
- Nausea — 1,194 reports (12.46%)
- Headache — 987 reports (10.3%)
- Dizziness — 933 reports (9.74%)
- Diarrhoea — 857 reports (8.94%)
- Dyspnoea — 800 reports (8.35%)
- Pain — 793 reports (8.28%)
- Asthenia — 736 reports (7.68%)
- Malaise — 679 reports (7.09%)
Levoxyl in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Levoxyl approved in United States?
Yes. FDA authorised it on 25 May 2001; FDA authorised it on 26 March 2009; FDA authorised it on 21 December 2018.
Who is the marketing authorisation holder for Levoxyl in United States?
KING PHARMS holds the US marketing authorisation.