Medicine
Oxistat 10 mg/mL lotion
Oxistat 10 mg/mL lotion is a prescription medicine containing Oxiconazole for topical use, marketed by ANI 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
Store at 20° to 25°C (68° to 77°F), excursions permitted at 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Oxiconazole
- Brand
- Oxistat
- Strength
- 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Packs
- 6 bottles, 1 bottle
- Marketing authorisation holder
- ANI Pharmaceuticals
- Manufacturer
- ANI Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted at 15° 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
- D01AC11 Oxiconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 September 2022
- Identifiers
- RxCUI 207249, 312140DailyMed set ID 64ef2286-0f56-4a8a-b07b-4a597f078ae0NDC 62559-285Application NDA020209
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 |
|---|---|---|---|
| 6 bottle in 1 carton / 7 mL in 1 bottle | 62559-285-06 | ANI Pharmaceuticals | 12 September 2022 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 62559-285-30 | ANI Pharmaceuticals | 12 September 2022 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 62559-285-60 | ANI Pharmaceuticals | 12 September 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 30 December 1988 | 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 Oxiconazole
Clinical summary
Oxiconazole is an azole antifungal indicated for the topical treatment of dermal infections. It is available as cream and lotion for topical use. MedsAcross supplies Oxiconazole 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 OxiconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Oxiconazole Nitrate prescribing information (E. Fougera) · U.S. National Library of Medicine, DailyMed
Need Oxistat 10 mg/mL lotion 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.