Medicine
Syndros 5 mg/mL oral solution
Syndros 5 mg/mL oral solution is a prescription medicine containing Dronabinol for oral use, marketed by Wellhouse 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. 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
Store in a refrigerator between 2°C and 8°C (36°F and 46°F), excursions…
Key facts
- Active ingredient (INN)
- Dronabinol
- Brand
- Syndros
- Strength
- 5 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Wellhouse Pharma
- Manufacturers
- Wellhouse PharmaBenuvia Operations
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator between 2°C and 8°C (36°F and 46°F), excursions permitted up to 25°C (77°F). The opened bottle can be stored at 25°C (77°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- A04AD10 Dronabinol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2017
- Identifiers
- RxCUI 1928948, 1928954DailyMed set ID a7801c70-995d-46a2-91ee-141ef427c6b5, 3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89NDC 78613-201, 85776-201Application NDA205525
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 bottle, glass in 1 carton / 30 mL in 1 bottle, glass | 85776-201-30 | Wellhouse Pharma | 16 April 2026 |
| 1 bottle, glass in 1 carton / 30 mL in 1 bottle, glass | 78613-201-30 | Benuvia Operations | 1 July 2017 |
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 31 May 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 Dronabinol 5 mg/mL oral solution.
Other strengths and forms of Dronabinol
Clinical summary
Dronabinol is a cannabinoid indicated in adults for the treatment of anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). It is available as capsules and oral solution. MedsAcross supplies Dronabinol 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 DronabinolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dronabinol prescribing information (Ascend Laboratories) · U.S. National Library of Medicine, DailyMed
Need Syndros 5 mg/mL oral solution 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.