← FDA DRUG APPROVALS

FDA NDA · NDA018332

INDOCIN

indomethacin

Sponsor: COSETTE

APPLICATION
NDA018332
TYPE
NDA
ORIGINAL APPROVAL
1985-10-10
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

INDOCIN · ReferencePrescription
INDOMETHACIN 25MG/5ML · SUSPENSION · ORAL

Approval history

2024-11-21Labeling · Supplement 43 · standard — Label ↗AP
2021-04-28Labeling · Supplement 42 · standard — Letter ↗AP
2019-03-26Labeling · Supplement 40 · standard — Label ↗AP
2016-05-09Labeling · Supplement 37 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 38 · standard — Letter ↗AP
2014-10-16Manufacturing (CMC) · Supplement 36 · standardAP
2013-05-09Manufacturing (CMC) · Supplement 35 · standardAP
2009-03-31Labeling · Supplement 32 · standard — Label ↗AP
2007-01-30Labeling · Supplement 30 · standard — Letter ↗AP
2006-01-26Labeling · Supplement 29 · standard — Label ↗AP
2005-03-24Labeling · Supplement 28 · standard — Letter ↗AP
2001-11-26Labeling · Supplement 23 · standardAP
2001-10-31Labeling · Supplement 21 · standardAP
1998-04-28Manufacturing (CMC) · Supplement 22 · standardAP
1994-12-30Manufacturing (CMC) · Supplement 18 · standardAP
1994-10-24Labeling · Supplement 20 · standardAP
1994-09-26Labeling · Supplement 17 · standardAP
1994-09-13Labeling · Supplement 19 · standardAP
1989-05-25Labeling · Supplement 14AP
1989-01-09Labeling · Supplement 11AP
1989-01-06Labeling · Supplement 9AP
1989-01-06Labeling · Supplement 13AP
1988-06-03Labeling · Supplement 6AP
1988-03-10Manufacturing (CMC) · Supplement 10 · standardAP
1986-09-19Labeling · Supplement 3AP
1986-08-15Labeling · Supplement 4AP
1986-06-04Manufacturing (CMC) · Supplement 2 · standardAP
1986-01-06Labeling · Supplement 1AP
1985-10-10Type 3 - New Dosage Form · Original · standardAP
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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