Medicine
Leuprolide 14 mg/2.8 mL injection
Leuprolide 14 mg/2.8 mL injection is a generic prescription medicine for subcutaneous use, 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
Do not freeze. Store below 77°F (25°C). Protect from light, store vial in…
Key facts
- Active ingredient (INN)
- Leuprolide
- Brand
- Sold under the generic name
- Strength
- 14 mg/2.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 carton of 2.8 mL
- Manufacturer
- Endo
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store below 77°F (25°C). Protect from light, store vial in carton until use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02AE02 Leuprorelin
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 June 2026
- Identifiers
- RxCUI 545835DailyMed set ID 290b0716-2fd5-43a1-8d3c-4857c1b2eefaNDC 42023-259Application ANDA217437
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 carton in 1 kit / 1 vial, multi-dose in 1 carton / 2.8 mL in 1 vial, multi-dose | 42023-259-00 | Endo | 30 June 2026 |
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
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 Leuprolide 14 mg/2.8 mL 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.