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Medicine

Leuprolide Acetate Depot kit

Leuprolide · Cipla
Available on requestPrescription onlyUS FDAIndian manufacturer

Leuprolide Acetate Depot kit is a prescription medicine containing Leuprolide, marketed by Cipla, 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

Available on request

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 20º-25ºC (68º-77ºF), excursions…

Key facts

Active ingredient (INN)
Leuprolide
Brand
Leuprolide Acetate Depot
Dosage form
Kit
Packs
1 kit
Marketing authorisation holder
Cipla
Manufacturer
CiplaIndia
Origin register
US FDA, United States
Storage
Store at controlled room temperature at 20º-25ºC (68º-77ºF), excursions permitted between 15ºC and 30ºC (59ºC and 86ºF).
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
15 July 2022
Identifiers
RxCUI 2606516DailyMed set ID 1563a30b-66e0-445d-ba3e-1ccd5218133fNDC 69097-909Application 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

PackCodeLabelerMarketed since
1 kit in 1 carton * 2 mL in 1 vial, single-dose * 2 mL in 1 syringe69097-909-50CiplaIndia15 July 2022

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 9 April 1985Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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.

Compare all 10

Other strengths and forms of Leuprolide

11.3514% injectable emulsion14 mg/2.8 mL injection22.5 mg/0.375 mL extended-release injectable suspension30 mg/0.5 mL extended-release injectable suspension45 mg/0.375 mL extended-release injectable suspension7% injectable emulsion7.5 mg/0.25 mL extended-release injectable suspensionSee all 23 presentations

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 Leuprolide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Leuprolide Acetate 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.

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