← FDA DRUG APPROVALS
FDA ANDA · ANDA208077
ARTHRITIS PAIN RELIEVER
diclofenac sodium
Sponsor: AMNEAL PHARMS
APPLICATION
ANDA208077
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-18
LATEST ACTION
2020-08-13
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter
Products
DICLOFENAC SODIUMOver-the-counter
DICLOFENAC SODIUM 1% · GEL · TOPICAL
Approval history
2020-08-13Labeling · Supplement 11 · standardAP
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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