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FDA ANDA · ANDA204132
DICLOFENAC SODIUM 1.5%
diclofenac sodium topical
Sponsor: LUPIN
APPLICATION
ANDA204132
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-20
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 1.5% · SOLUTION · TOPICAL
Approval history
2024-11-21Labeling · Supplement 10 · standardAP
2021-08-24Labeling · Supplement 5 · standardAP
2021-04-28Labeling · Supplement 6 · standardAP
2020-02-14Labeling · Supplement 2 · 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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