← FDA DRUG APPROVALS

FDA ANDA · ANDA212333

ISOTRETINOIN

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA212333
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-21
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ISOTRETINOINPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL

Approval history

2026-02-09REMS · Supplement 10AP
2023-03-24REMS · Supplement 8AP
2022-10-06REMS · Supplement 6AP
2022-08-24Labeling · Supplement 3 · standardAP
2021-10-08REMS · Supplement 1AP
2021-09-21UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →