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FDA NDA · NDA018829

INDOMETHACIN

Sponsor: CHARTWELL MOLECULES

APPLICATION
NDA018829
TYPE
NDA
ORIGINAL APPROVAL
1984-08-06
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

INDOMETHACINPrescription
INDOMETHACIN 25MG · CAPSULE · ORAL
INDOMETHACINPrescription
INDOMETHACIN 50MG · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 25 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 23 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 22 · standard — Letter ↗AP
1996-07-26Labeling · Supplement 21AP
1996-06-07Manufacturing (CMC) · Supplement 20AP
1992-05-27Labeling · Supplement 19AP
1991-04-29Labeling · Supplement 18AP
1989-06-08Labeling · Supplement 17AP
1989-05-02Manufacturing (CMC) · Supplement 14AP
1989-03-21Labeling · Supplement 16AP
1988-11-09Labeling · Supplement 15AP
1987-10-28Manufacturing (CMC) · Supplement 12AP
1986-04-14Manufacturing (CMC) · Supplement 9AP
1986-04-14Manufacturing (CMC) · Supplement 7AP
1985-06-19Manufacturing (CMC) · Supplement 2AP
1985-06-19Manufacturing (CMC) · Supplement 5AP
1985-06-19Manufacturing (CMC) · Supplement 1AP
1984-08-06OriginalAP
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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