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FDA ANDA · ANDA202027
VAROPHEN
diclofenac sodium and menthol, methyl salicylate
Sponsor: APOTEX
APPLICATION
ANDA202027
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-27
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
DICLOFENAC SODIUMDiscontinued
DICLOFENAC SODIUM 1.5% · SOLUTION · TOPICAL
Approval history
2024-11-21Labeling · Supplement 10 · standardAP
2021-04-28Labeling · Supplement 9 · standardAP
2017-10-20Labeling · Supplement 4 · standardAP
2017-10-20Manufacturing (CMC) · Supplement 3AP
2014-05-27Not Applicable · OriginalAP
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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