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FDA NDA · NDA019645

TORADOL

Sponsor: ROCHE PALO

APPLICATION
NDA019645
TYPE
NDA
ORIGINAL APPROVAL
1991-12-20
LATEST ACTION
2013-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TORADOL · ReferenceDiscontinued
KETOROLAC TROMETHAMINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2013-03-26Labeling · Supplement 19 · standard — Medication Guide ↗AP
2008-12-16Labeling · Supplement 18 · standard — Letter ↗AP
2007-11-13Labeling · Supplement 17 · standard — Label ↗AP
2007-01-19Labeling · Supplement 16 · standard — Letter ↗AP
2001-10-11Labeling · Supplement 8 · standardAP
2001-10-11Labeling · Supplement 6 · standardAP
2001-10-11Labeling · Supplement 9 · standardAP
2001-10-11Labeling · Supplement 7 · standardAP
2001-10-11Labeling · Supplement 5 · standardAP
2001-10-11Labeling · Supplement 3 · standardAP
1994-12-07Labeling · Supplement 4 · standardAP
1992-09-18Manufacturing (CMC) · Supplement 1 · standardAP
1991-12-20Type 3 - New Dosage Form · 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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