← FDA DRUG APPROVALS

FDA NDA · NDA021951

ABSORICA

isotretinoin

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA021951
TYPE
NDA
ORIGINAL APPROVAL
2012-05-25
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ABSORICA · ReferencePrescription
ISOTRETINOIN 35MG · CAPSULE · ORAL
ABSORICA · ReferencePrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
ABSORICA · ReferencePrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ABSORICA · ReferencePrescription
ISOTRETINOIN 25MG · CAPSULE · ORAL
ABSORICA · ReferencePrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ABSORICA · ReferencePrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL

Approval history

2026-06-12Labeling · Supplement 29 · standard — Label ↗AP
2026-02-09REMS · Supplement 28 — Letter ↗AP
2024-06-28Labeling · Supplement 16 · standard — Label ↗AP
2023-07-18Labeling · Supplement 24 · standard — Label ↗AP
2023-07-18Labeling · Supplement 23 · standard — Letter ↗AP
2023-03-24REMS · Supplement 22 — Letter ↗AP
2022-10-06REMS · Supplement 21 — Letter ↗AP
2021-10-08REMS · Supplement 18 — Letter ↗AP
2020-12-09REMS · Supplement 17 — Letter ↗AP
2020-01-24REMS · Supplement 15 — Letter ↗AP
2019-11-07Labeling · Supplement 13 · standard — Letter ↗AP
2018-08-31Labeling · Supplement 14 · standard — Letter ↗AP
2018-05-02Labeling · Supplement 11 · standard — Letter ↗AP
2018-04-23REMS · Supplement 12 — Letter ↗AP
2017-06-17REMS · Supplement 10 — Letter ↗AP
2016-07-08REMS · Supplement 8 — Letter ↗AP
2016-02-04REMS · Supplement 7 — Letter ↗AP
2015-12-23Manufacturing (CMC) · Supplement 6 · standardAP
2015-09-03REMS · Supplement 5 — Label ↗AP
2014-10-20Manufacturing (CMC) · Supplement 4 · standardAP
2014-08-15Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2014-07-30Labeling · Supplement 1 · unknown — Label ↗AP
2012-05-25Type 3 - New Dosage Form · Original · standard — Review ↗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 →