← FDA Drug Approvals (Drugs@FDA)
MYORISAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2012-01-19
Drug application
- FDA Application #
ANDA076485- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MYORISAN
- Generic name
- ISOTRETINOIN
- Active ingredients
- ISOTRETINOIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- UPSHER SMITH LABS
- Manufacturer
- Mayne Pharma
- First approval
- 2012-01-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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