Medicine
Jalyn 0.5 mg/0.4 mg capsule
Jalyn 0.5 mg/0.4 mg capsule is a prescription medicine containing Dutasteride and Tamsulosin for oral use, marketed by Waylis Therapeutics, 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 25°C (77°F), excursions permitted 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Dutasteride and Tamsulosin
- Brand
- Jalyn
- Strength
- 0.5 mg/0.4 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules
- Marketing authorisation holder
- Waylis Therapeutics
- Manufacturer
- Waylis Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04CA52 Dutasteride and Tamsulosin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2024
- Identifiers
- RxCUI 996097, 996101DailyMed set ID aab9a2d4-5328-40f3-986f-e7753a928bc0NDC 80725-809Application NDA022460
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 |
|---|---|---|---|
| 30 capsule in 1 bottle, plastic | 80725-809-13 | Waylis Therapeutics | 1 March 2024 |
| 90 capsule in 1 bottle, plastic | 80725-809-59 | Waylis Therapeutics | 1 March 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 14 June 2010 | 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 Dutasteride and Tamsulosin 0.5 mg/0.4 mg capsule.
Clinical summary
Dutasteride and Tamsulosin is a fixed-dose combination of a 5-alpha reductase inhibitor and an alpha-adrenergic blocker indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. MedsAcross supplies Dutasteride and Tamsulosin 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 Dutasteride and TamsulosinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Jalyn prescribing information (Waylis Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Jalyn 0.5 mg/0.4 mg capsule 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.