Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A213571
Product Number: 001
Approval Date: Apr 12, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:
Prescription
Patent and Exclusivity Information