Medicine
Loteprednol etabonate and Tobramycin 5 mg/3 mg per mL ophthalmic suspension
Loteprednol etabonate and Tobramycin 5 mg/3 mg per mL ophthalmic suspension is a generic prescription medicine for ophthalmic use, 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
PROTECT FROM FREEZING. Store upright at 15ºC to 25ºC (59ºF to 77ºF).
Key facts
- Active ingredient (INN)
- Loteprednol etabonate and Tobramycin
- Brand
- Sold under the generic name
- Strength
- 5 mg/3 mg per mL
- Dosage form
- Ophthalmic suspension
- Route
- Ophthalmic
- Packs
- 1 bottle and 1 more
- Manufacturer
- Alembic PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- PROTECT FROM FREEZING. Store upright at 15ºC to 25ºC (59ºF to 77ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 December 2025
- Identifiers
- RxCUI 545255DailyMed set ID a6d68829-f7b6-4b9b-ad44-110c47609918, 7c752fac-8ec8-49ab-8570-09d2aabbeef0NDC 46708-801, 62332-801Application ANDA217597
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 in 1 carton / 5 mL in 1 bottle | 46708-801-05 | Alembic PharmaceuticalsIndia | 10 December 2025 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 46708-801-10 | Alembic PharmaceuticalsIndia | 10 December 2025 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 62332-801-05 | Alembic PharmaceuticalsIndia | 10 December 2025 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 62332-801-10 | Alembic PharmaceuticalsIndia | 10 December 2025 |
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 December 2004 | 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 Loteprednol etabonate and Tobramycin 5 mg/3 mg per mL ophthalmic suspension.
Other strengths and forms of Loteprednol etabonate and Tobramycin
Clinical summary
Loteprednol etabonate and Tobramycin is a fixed-dose combination of an aminoglycoside antibacterial and a corticosteroid indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists, among other approved uses. MedsAcross supplies Loteprednol etabonate and Tobramycin 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 Loteprednol etabonate and TobramycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Loteprednol etabonate and tobramycin prescribing information (Bausch & Lomb Americas) · U.S. National Library of Medicine, DailyMed
Need Loteprednol etabonate and Tobramycin 5 mg/3 mg per mL ophthalmic suspension 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.