General MedicationsORALStandard
ISOTRETINOIN
ISOTRETINOIN
Standard Dose
30MG
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Prescription
Summary
Approval overview ISOTRETINOIN is listed in Drugs@FDA under application 218194 (ANDA).
Marketing status: Prescription Active ingredient ISOTRETINOIN Form and strength CAPSULE;ORAL - 30MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2026-02-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview ISOTRETINOIN is listed in Drugs@FDA under application 218194 (ANDA). Marketing status: Prescription Active ingredient ISOTRETINOIN Form and strength CAPSULE;ORAL - 30MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2026-02-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Review priority: N/A
- • Marketing status: Prescription
Interaction Notes
- No interaction notes stored yet.