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FDA ANDA · ANDA215548

FENOPROFEN CALCIUM

Sponsor: MISEMER

APPLICATION
ANDA215548
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-16
LATEST ACTION
2023-05-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 300MG BASE · CAPSULE · ORAL
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 400MG BASE · CAPSULE · ORAL
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 200MG BASE · CAPSULE · ORAL

Approval history

2023-05-16UNKNOWN · Original · standardAP
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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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