# Amnesteem

NDC: 0378-6612
Generic name: isotretinoin
Labeler / Manufacturer: Mylan Pharmaceuticals Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: CAPSULE
Routes: ORAL
Marketing started: 20021111

FDA application: ANDA075945

## Active ingredients

- ISOTRETINOIN: 20 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0378-6612"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0378-6612
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b2cb63c9-f825-4991-9a2c-6260f1bbcc2c