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FDA NDA · NDA018851

INDOMETHACIN

Sponsor: HERITAGE

APPLICATION
NDA018851
TYPE
NDA
ORIGINAL APPROVAL
1984-05-18
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

INDOMETHACINDiscontinued
INDOMETHACIN 50MG · CAPSULE · ORAL
INDOMETHACINDiscontinued
INDOMETHACIN 25MG · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 29 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 28 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 25 · standard — Label ↗AP
1992-08-07Labeling · Supplement 23AP
1990-05-25Manufacturing (CMC) · Supplement 20AP
1989-10-04Labeling · Supplement 22AP
1989-10-04Labeling · Supplement 31AP
1989-03-16Labeling · Supplement 30AP
1989-03-16Labeling · Supplement 21AP
1989-02-13Manufacturing (CMC) · Supplement 19AP
1989-02-13Manufacturing (CMC) · Supplement 17AP
1988-02-23Manufacturing (CMC) · Supplement 18AP
1987-05-14Manufacturing (CMC) · Supplement 13AP
1986-08-19Manufacturing (CMC) · Supplement 14AP
1985-10-24Manufacturing (CMC) · Supplement 8AP
1985-10-24Manufacturing (CMC) · Supplement 10AP
1985-10-24Manufacturing (CMC) · Supplement 9AP
1984-05-18OriginalAP
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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