Medicine
Letybo 50 units powder for injection
Letybo 50 units powder for injection is a prescription medicine containing Letibotulinumtoxina for intramuscular use, marketed by Hugel, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Unopened LETYBO vials should be stored in a refrigerator between 2°C to 8°C…
Key facts
- Active ingredient (INN)
- Letibotulinumtoxina
- Brand
- Letybo
- Strength
- 50 units
- Dosage form
- Powder for injection
- Route
- Intramuscular
- Packs
- 1 vial
- Marketing authorisation holder
- Hugel
- Manufacturer
- Hugel
- Origin register
- US FDA, United States
- Storage
- Unopened LETYBO vials should be stored in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 July 2024
- Identifiers
- RxCUI 2689290, 2689297, 2689299 +1DailyMed set ID 910e5d0e-4d0b-4de8-8e2d-97879a044181NDC 81165-050Application BLA761225
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 81165-050-01 | Hugel | 30 July 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 February 2024 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Letibotulinumtoxina
Clinical summary
Letibotulinumtoxina is an acetylcholine release inhibitor indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. MedsAcross supplies Letibotulinumtoxina for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LetibotulinumtoxinaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LETYBO prescribing information (Hugel) · U.S. National Library of Medicine, DailyMed
Need Letybo 50 units powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.