APPLICATION
ANDA075419
TYPE
ANDA
ORIGINAL APPROVAL
2000-07-28
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ETODOLACPrescription
ETODOLAC 300MG · CAPSULE · ORAL
ETODOLACPrescription
ETODOLAC 200MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 16 · standardAP
2024-07-08Labeling · Supplement 15 · standardAP
2021-04-29Labeling · Supplement 13 · standardAP
2016-05-09Labeling · Supplement 10 · standardAP
2013-02-07Labeling · Supplement 8AP
2006-04-25Labeling · Supplement 5AP
2001-11-15Manufacturing (CMC) · Supplement 1AP
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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