APPLICATION
ANDA206136
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-20
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PIROXICAMDiscontinued
PIROXICAM 10MG · CAPSULE · ORAL
PIROXICAMDiscontinued
PIROXICAM 20MG · CAPSULE · ORAL
Approval history
2026-06-25Labeling · Supplement 8 · standardAP
2023-02-21Labeling · Supplement 7 · standardAP
2023-02-21Labeling · Supplement 6 · standardAP
2019-12-23Labeling · Supplement 4 · standardAP
2018-07-23Manufacturing (CMC) · Supplement 3AP
2017-06-20UNKNOWN · 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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