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FDA NDA · NDA021234

FLECTOR

diclofenac epolamine

Sponsor: IBSA

APPLICATION
NDA021234
TYPE
NDA
ORIGINAL APPROVAL
2007-01-31
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

FLECTOR · ReferencePrescription
DICLOFENAC EPOLAMINE 1.3% · SYSTEM · TOPICAL

Approval history

2024-11-21Labeling · Supplement 24 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 19 · standard — Letter ↗AP
2019-03-01Efficacy · Supplement 16 · standard — Label ↗AP
2019-03-01Labeling · Supplement 17 · standard — Label ↗AP
2018-08-30Labeling · Supplement 15 · standard — Label ↗AP
2016-05-09Labeling · Supplement 14 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 13 · standard — Letter ↗AP
2013-05-08Manufacturing (CMC) · Supplement 10 · standardAP
2011-02-23Labeling · Supplement 9 · standard — Letter ↗AP
2011-01-31Labeling · Supplement 5 · standard — Letter ↗AP
2011-01-31Labeling · Supplement 8 · unknown — Letter ↗AP
2009-09-03Labeling · Supplement 6 · unknown — Label ↗AP
2009-09-03Labeling · Supplement 7 · unknown — Label ↗AP
2008-10-23Labeling · Supplement 4 · standard — Letter ↗AP
2008-06-04Labeling · Supplement 3 · standard — Letter ↗AP
2007-01-31Type 2 - New Active Ingredient · Original · standard — Review ↗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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