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FDA ANDA · ANDA074148

PIROXICAM

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA074148
TYPE
ANDA
ORIGINAL APPROVAL
1996-06-03
LATEST ACTION
2002-04-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PIROXICAMDiscontinued
PIROXICAM 20MG · CAPSULE · ORAL
PIROXICAMDiscontinued
PIROXICAM 10MG · CAPSULE · ORAL

Approval history

2002-04-08Manufacturing (CMC) · Supplement 7AP
2002-04-08Manufacturing (CMC) · Supplement 6AP
2002-03-12Manufacturing (CMC) · Supplement 8AP
2001-06-08Manufacturing (CMC) · Supplement 5AP
2000-09-22Manufacturing (CMC) · Supplement 1AP
2000-09-22Manufacturing (CMC) · Supplement 2AP
2000-01-28Manufacturing (CMC) · Supplement 4AP
1996-06-03OriginalAP
VIEW ON DRUGS@FDA ↗

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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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