Medicine
Akten 35 mg/mL ophthalmic gel
Akten 35 mg/mL ophthalmic gel is a prescription medicine containing Lidocaine for ophthalmic use, marketed by Thea 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and…
Key facts
- Active ingredient (INN)
- Lidocaine
- Brand
- Akten
- Strength
- 35 mg/mL
- Dosage form
- Ophthalmic gel
- Route
- Ophthalmic
- Packs
- 1 tube, 25 tubes
- Marketing authorisation holder
- Thea Pharma
- Manufacturer
- Thea Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BB01 Lidocaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2022
- Identifiers
- RxCUI 1009462, 1011703DailyMed set ID 70ff9fb7-d323-4fe6-b1b1-6033e05f0749NDC 82584-792Application NDA022221
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 tube in 1 carton / 1 mL in 1 tube | 82584-792-01 | Thea Pharma | 1 December 2022 |
| 25 tube in 1 carton / 1 mL in 1 tube | 82584-792-25 | Thea Pharma | 1 December 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 19 November 1948 | 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 Lidocaine
Clinical summary
Lidocaine is an amide local anesthetic. It is available as injection, ointment and patches for infiltration, perineural and topical use. MedsAcross supplies Lidocaine 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 LidocaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xylocaine prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Akten 35 mg/mL ophthalmic gel 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.