FDA ANDA · ANDA210986
DICLOFENAC SODIUM
diclofenac sodium topical gel, 1%
Sponsor: ENCUBE
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APPLICATION
ANDA210986
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-27
LATEST ACTION
2026-10-05
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter
Products
DICLOFENAC SODIUMOver-the-counter
DICLOFENAC SODIUM 1% · GEL · TOPICAL
Approval history
2026-10-05Labeling · Supplement 27 · standardAP
2025-09-26Labeling · Supplement 5 · standardAP
2020-08-11Labeling · Supplement 1 · standardAP
2020-01-27UNKNOWN · Original · standardAP
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