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FDA NDA · NDA018878

INDOCIN

Sponsor: RECORDATI RARE

APPLICATION
NDA018878
TYPE
NDA
ORIGINAL APPROVAL
1985-01-30
LATEST ACTION
2021-03-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

INDOCIN · ReferenceDiscontinued
INDOMETHACIN SODIUM EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2021-03-26Labeling · Supplement 29 · standard — Label ↗AP
2010-01-19Labeling · Supplement 27 · unknown — Letter ↗AP
2007-01-12Labeling · Supplement 24 · standard — Label ↗AP
2006-02-01Labeling · Supplement 23 · standard — Letter ↗AP
2003-05-06Labeling · Supplement 18 · standard — Letter ↗AP
2003-05-06Labeling · Supplement 19 · standard — Letter ↗AP
2002-11-08Manufacturing (CMC) · Supplement 20 · priorityAP
2001-02-12Manufacturing (CMC) · Supplement 17 · priorityAP
2000-11-16Manufacturing (CMC) · Supplement 16 · priorityAP
2000-10-24Manufacturing (CMC) · Supplement 15 · priorityAP
1998-05-15Labeling · Supplement 14 · standardAP
1997-10-14Manufacturing (CMC) · Supplement 13 · priorityAP
1994-09-21Labeling · Supplement 10AP
1994-09-13Labeling · Supplement 11 · standardAP
1988-06-08Labeling · Supplement 5AP
1986-10-31Manufacturing (CMC) · Supplement 1 · priorityAP
1985-06-20Labeling · Supplement 2AP
1985-01-30Type 3 - New Dosage Form · Original · priorityAP
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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