Medicine
Sympazan 5 mg oral film
Sympazan 5 mg oral film is a prescription medicine containing Clobazam for oral use, marketed by Aquestive 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 SYMPAZAN ® oral film pouches (sachets) at 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Clobazam
- Brand
- Sympazan
- Strength
- 5 mg
- Dosage form
- Oral film
- Route
- Oral
- Packs
- 60 pouches
- Marketing authorisation holder
- Aquestive Therapeutics
- Manufacturer
- Aquestive Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store SYMPAZAN ® oral film pouches (sachets) at 20°C to 25°C (68°F to 77°F), Excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05BA09 Clobazam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2018
- Identifiers
- RxCUI 2058253, 2058254, 2058255 +3DailyMed set ID 5e3d8fcb-aa7d-4822-88fc-4f06264c3242NDC 10094-205Application NDA210833
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 |
|---|---|---|---|
| 60 pouch in 1 package / 1 film in 1 pouch | 10094-205-60 | Aquestive Therapeutics | 1 November 2018 |
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 21 October 2011 | 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 Clobazam
Clinical summary
Clobazam is a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. It is available as tablets, oral suspension and oral films. MedsAcross supplies Clobazam 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 ClobazamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Onfi prescribing information (Lundbeck Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Sympazan 5 mg oral film 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.