← FDA DRUG APPROVALS

FDA NDA · NDA206976

LICART

diclofenac epolamine

Sponsor: IBSA INST BIO

APPLICATION
NDA206976
TYPE
NDA
ORIGINAL APPROVAL
2018-12-19
LATEST ACTION
2026-03-27
ROUTE
TOPICAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

LICART · ReferencePrescription
DICLOFENAC EPOLAMINE 1.3% · SYSTEM · TOPICAL

Approval history

2026-03-27Efficacy · Supplement 18 · standard — Label ↗AP
2024-11-21Labeling · Supplement 16 · standard — Letter ↗AP
2024-05-23Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2021-04-28Labeling · Supplement 7 · standard — Letter ↗AP
2020-05-14Labeling · Supplement 2 · standard — Letter ↗AP
2020-01-13Labeling · Supplement 3 · standard — Letter ↗AP
2018-12-19Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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