Medicine
Eprontia 25 mg/mL oral solution
Eprontia 25 mg/mL oral solution is a prescription medicine containing Topiramate for oral use, marketed by Azurity Pharmaceuticals, 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
EPRONTIA is stored at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Topiramate
- Brand
- Eprontia
- Strength
- 25 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 1 bottle
- Marketing authorisation holder
- Azurity Pharmaceuticals
- Manufacturer
- Azurity Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- EPRONTIA is stored at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C 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
- N03AX11 Topiramate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 December 2021
- Identifiers
- RxCUI 2586427, 2586433DailyMed set ID e2a4df59-fead-4a01-9021-9eda02c48010NDC 52652-9001Application NDA214679
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 |
|---|---|---|---|
| 473 mL in 1 bottle | 52652-9001-1 | Azurity Pharmaceuticals | 6 December 2021 |
| 1 bottle in 1 carton / 240 mL in 1 bottle | 52652-9001-2 | Azurity Pharmaceuticals | 2 January 2023 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 52652-9001-3 | Azurity Pharmaceuticals | 2 January 2023 |
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 24 December 1996 | 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 Topiramate 25 mg/mL oral solution.
Other strengths and forms of Topiramate
Clinical summary
Topiramate is a prescription medicine indicated for epilepsy, among other approved uses. It is available as tablets, extended-release capsules and capsules for oral use. MedsAcross supplies Topiramate 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 TopiramateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Topamax prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Eprontia 25 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.