APPLICATION
ANDA074118
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-15
LATEST ACTION
2019-12-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PIROXICAMPrescription
PIROXICAM 10MG · CAPSULE · ORAL
PIROXICAMPrescription
PIROXICAM 20MG · CAPSULE · ORAL
Approval history
2019-12-23Labeling · Supplement 12 · standardAP
2019-12-23Labeling · Supplement 10 · standardAP
2015-06-30Labeling · Supplement 8 · standardAP
2015-06-30Labeling · Supplement 9 · standardAP
2015-06-30Labeling · Supplement 5 · standardAP
2011-10-21Labeling · Supplement 3AP
2011-09-14Labeling · Supplement 4AP
1993-06-15OriginalAP
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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