APPLICATION
ANDA091276
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-22
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 50MG · CAPSULE · ORAL
INDOMETHACINPrescription
INDOMETHACIN 25MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 10 · standardAP
2021-04-28Labeling · Supplement 6 · standardAP
2020-02-02Labeling · Supplement 3 · standardAP
2020-02-02Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 2 · standardAP
2010-12-22OriginalAP
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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