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FDA ANDA · ANDA211253
ARTHRITIS PAIN RELIEVER
diclofenac sodium
Sponsor: PERRIGO PHARMA INTL
APPLICATION
ANDA211253
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-16
LATEST ACTION
2022-09-28
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter
Products
DICLOFENAC SODIUMOver-the-counter
DICLOFENAC SODIUM 1% · GEL · TOPICAL
Approval history
2022-09-28Manufacturing (CMC) · Supplement 14 · unknownAP
2020-10-23Manufacturing (CMC) · Supplement 7AP
2020-10-23Manufacturing (CMC) · Supplement 10AP
2020-04-01Labeling · Supplement 5 · standardAP
2019-05-16UNKNOWN · Original · 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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