FDA ANDA · ANDA216097
ISOTRETINOIN
Sponsor: AMNEAL PHARMS NY
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA216097
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-07
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ISOTRETINOINDiscontinued
ISOTRETINOIN 40MG · CAPSULE · ORAL
ISOTRETINOINDiscontinued
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINDiscontinued
ISOTRETINOIN 20MG · CAPSULE · ORAL
ISOTRETINOINDiscontinued
ISOTRETINOIN 35MG · CAPSULE · ORAL
ISOTRETINOINDiscontinued
ISOTRETINOIN 25MG · CAPSULE · ORAL
ISOTRETINOINDiscontinued
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 3AP
2026-02-09REMS · Supplement 1AP
2025-10-07UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →