Medicine
Amnesteem 20 mg capsule
Amnesteem 20 mg capsule is a prescription medicine containing Isotretinoin for oral use, marketed by Mylan 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 68° to 77°F (20° to 25°C). Protect from light.
Key facts
- Active ingredient (INN)
- Isotretinoin
- Brand
- Amnesteem
- Strength
- 20 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 3 blister pack
- Marketing authorisation holder
- Mylan Pharmaceuticals
- Manufacturer
- Mylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 68° to 77°F (20° to 25°C). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AD04 Isotretinoin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 November 2002
- Identifiers
- RxCUI 197843, 197844, 197845 +5DailyMed set ID b2cb63c9-f825-4991-9a2c-6260f1bbcc2cNDC 0378-6612Application ANDA075945
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 |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 0378-6612-93 | Mylan Pharmaceuticals | 11 November 2002 |
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 7 May 1982 | 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 Isotretinoin 20 mg capsule.
- Isotretinoin 20 mg capsuleAvailable on request—US FDA16 packs
- Zenatane 20 mg capsuleAvailable on requestDr. Reddy's LaboratoriesIndiaUS FDA2 packs
- Claravis 20 mg capsuleAvailable on requestTeva PharmaceuticalsUS FDA2 packs
- Absorica 20 mg capsuleAvailable on requestSun Pharmaceutical IndustriesIndiaUS FDA1 pack
- Accutane 20 mg capsuleAvailable on requestJG PharmaUS FDA1 pack
Other strengths and forms of Isotretinoin
Clinical summary
Isotretinoin is a retinoid indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. MedsAcross supplies Isotretinoin 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 IsotretinoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Absorica LD prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Amnesteem 20 mg capsule 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.