Medicine
Clobetasol Propionate ANDA 0.05% ointment
Clobetasol Propionate ANDA 0.05% ointment is a prescription medicine containing Clobetasol propionate for topical use, marketed by Macleods 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
Do not refrigerate. Store at 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Clobetasol propionate
- Brand
- Clobetasol Propionate ANDA
- Strength
- 0.05%
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 1 tube and 1 more
- Marketing authorisation holder
- Macleods Pharmaceuticals
- Manufacturer
- Macleods PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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
- 28 December 2023
- Identifiers
- RxCUI 861448DailyMed set ID 92cf4231-e301-4353-98d9-85206ec6ba96NDC 33342-506Application ANDA215990
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 / 15 g in 1 tube | 33342-506-15 | Macleods PharmaceuticalsIndia | 28 December 2023 |
| 1 tube in 1 carton / 30 g in 1 tube | 33342-506-30 | Macleods PharmaceuticalsIndia | 28 December 2023 |
| 1 tube in 1 carton / 45 g in 1 tube | 33342-506-45 | Macleods PharmaceuticalsIndia | 28 December 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 33342-506-60 | Macleods PharmaceuticalsIndia | 28 December 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 27 December 1985 | 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 Clobetasol propionate 0.05% ointment.
Other strengths and forms of Clobetasol propionate
Clinical summary
Clobetasol propionate is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older, among other approved uses. MedsAcross supplies Clobetasol propionate 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 Clobetasol propionateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- clobetasol propionate prescribing information (Mayne Pharma) · U.S. National Library of Medicine, DailyMed
Need Clobetasol Propionate ANDA 0.05% ointment 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.