Lutrate Depot kit is a prescription medicine containing Leuprolide, marketed by Avyxa Pharma, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at controlled room temperature at 20°-25°C (68°-77°F), excursions…
Key facts
- Active ingredient (INN)
- Leuprolide
- Brand
- Lutrate Depot
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Avyxa Pharma
- Manufacturer
- Avyxa Pharma
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature at 20°-25°C (68°-77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02AE02 Leuprorelin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 March 2025
- Identifiers
- RxCUI 2606516, 2709448DailyMed set ID 3a6d1373-17d9-4289-b62f-d299ffe55831NDC 83831-134Application NDA205054
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 kit in 1 carton * 2 mL in 1 vial, single-dose * 2 mL in 1 syringe | 83831-134-01 | Avyxa Pharma | 26 March 2025 |
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 9 April 1985 | 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
Alternatives
Other makers and brands of Leuprolide kit.
- Lupron Depot kitAvailable on requestAbbVieUS FDA6 packs
- Lupron Depot-PED kitAvailable on requestAbbVieUS FDA6 packs
- Lupron Depot kitAvailable on requestAbbVieUS FDA2 packs
- Eligard kitAvailable on requestTolmarUS FDA1 pack Cold chain
- Eligard kitAvailable on requestTolmarUS FDA1 pack Cold chain
- Eligard kitAvailable on requestTolmarUS FDA1 pack Cold chain
Other strengths and forms of Leuprolide
Clinical summary
Leuprolide is a gonadotropin releasing hormone receptor agonist indicated for the treatment of advanced prostate cancer. It is available as kits, extended-release injectable suspension and injectable emulsion for subcutaneous use. MedsAcross supplies Leuprolide 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 LeuprolideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lupron Depot prescribing information (AbbVie) · U.S. National Library of Medicine, DailyMed
Need Lutrate Depot kit 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.