← FDA DRUG APPROVALS

FDA NDA · NDA211913

ABSORICA LD

isotretinoin

Sponsor: SUN PHARM

APPLICATION
NDA211913
TYPE
NDA
ORIGINAL APPROVAL
2019-11-05
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

ABSORICA LD · ReferenceDiscontinued
ISOTRETINOIN 28MG · CAPSULE · ORAL
ABSORICA LD · ReferenceDiscontinued
ISOTRETINOIN 20MG · CAPSULE · ORAL
ABSORICA LD · ReferencePrescription
ISOTRETINOIN 8MG · CAPSULE · ORAL
ABSORICA LD · ReferencePrescription
ISOTRETINOIN 32MG · CAPSULE · ORAL
ABSORICA LD · ReferencePrescription
ISOTRETINOIN 24MG · CAPSULE · ORAL
ABSORICA LD · ReferencePrescription
ISOTRETINOIN 16MG · CAPSULE · ORAL

Approval history

2026-06-12Labeling · Supplement 14 · standard — Letter ↗AP
2026-02-09REMS · Supplement 13 — Letter ↗AP
2023-07-18Labeling · Supplement 11 · standard — Letter ↗AP
2023-03-24REMS · Supplement 10 — Letter ↗AP
2022-10-06REMS · Supplement 9 — Letter ↗AP
2022-04-07Labeling · Supplement 5 · standard — Letter ↗AP
2021-10-08REMS · Supplement 4 — Letter ↗AP
2020-12-09REMS · Supplement 3 — Letter ↗AP
2019-11-05New Combination and New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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