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Medicine

Neo-Synalar 0.25 mg/3.5 mg per g cream

Fluocinolone acetonide and Neomycin · Topical · Eurofarma
Available on requestPrescription onlyUS FDA

Neo-Synalar 0.25 mg/3.5 mg per g cream is a prescription medicine containing Fluocinolone acetonide and Neomycin for topical use, marketed by Eurofarma, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at room temperature 15-25°C (59-77°F), avoid freezing and excessive heat…

Key facts

Active ingredient (INN)
Fluocinolone acetonide and Neomycin
Brand
Neo-Synalar
Strength
0.25 mg/3.5 mg per g
Dosage form
Cream
Route
Topical
Packs
1 tube, 4 tubes
Marketing authorisation holder
Eurofarma
Manufacturer
Eurofarma
Origin register
US FDA, United States
Storage
Store at room temperature 15-25°C (59-77°F), avoid freezing and excessive heat above 40°C (104°F).
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
11 June 1963
Identifiers
RxCUI 1191359, 1542994DailyMed set ID 1141956e-8a4c-4f80-95d1-f15bdb57fdf6NDC 43538-940Application ANDA060700

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

PackCodeLabelerMarketed since
1 tube in 1 carton / 60 g in 1 tube43538-940-60Eurofarma11 June 1963
4 tube in 1 carton / 3 g in 1 tube43538-940-99Eurofarma11 June 1963

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAApprovedDrugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Clinical summary

Fluocinolone acetonide and Neomycin is a fixed-dose combination of an aminoglycoside antibacterial and a corticosteroid indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It is available as cream for topical use. MedsAcross supplies Fluocinolone acetonide and Neomycin 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 Fluocinolone acetonide and Neomycin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Neo-Synalar 0.25 mg/3.5 mg per g cream 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.