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FDA NDA · NDA016059

INDOCIN

Sponsor: ZYLA LIFE SCIENCES

APPLICATION
NDA016059
TYPE
NDA
ORIGINAL APPROVAL
1965-06-10
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

INDOCIN · ReferenceDiscontinued
INDOMETHACIN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
INDOCIN · ReferenceDiscontinued
INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 102 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 101 · standard — Letter ↗AP
2019-03-26Labeling · Supplement 100 · standard — Label ↗AP
2016-05-09Labeling · Supplement 99 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 98 · standard — Label ↗AP
2007-01-30Labeling · Supplement 97 · standard — Letter ↗AP
2006-01-26Labeling · Supplement 96 · standard — Label ↗AP
2005-03-24Labeling · Supplement 95 · standard — Letter ↗AP
2001-10-31Labeling · Supplement 88 · standardAP
1997-12-01Manufacturing (CMC) · Supplement 90 · priorityAP
1996-03-01Manufacturing (CMC) · Supplement 89 · priorityAP
1994-12-30Manufacturing (CMC) · Supplement 84 · priorityAP
1994-10-24Labeling · Supplement 87 · standardAP
1994-09-26Labeling · Supplement 82 · standardAP
1994-09-14Labeling · Supplement 83 · standardAP
1994-09-13Labeling · Supplement 86 · standardAP
1994-08-18Manufacturing (CMC) · Supplement 85 · priorityAP
1991-04-04Manufacturing (CMC) · Supplement 79 · priorityAP
1989-05-25Labeling · Supplement 78AP
1989-01-09Labeling · Supplement 75AP
1989-01-06Labeling · Supplement 77AP
1989-01-06Labeling · Supplement 73AP
1988-06-03Labeling · Supplement 71AP
1988-05-03Manufacturing (CMC) · Supplement 74 · priorityAP
1986-09-22Labeling · Supplement 68AP
1986-08-15Labeling · Supplement 62AP
1986-08-15Labeling · Supplement 67AP
1986-06-04Labeling · Supplement 65AP
1986-01-06Efficacy · Supplement 45AP
1985-07-23Labeling · Supplement 61AP
1984-12-06Labeling · Supplement 59AP
1984-11-27Labeling · Supplement 60AP
1984-08-13Manufacturing (CMC) · Supplement 47 · priorityAP
1984-06-25Manufacturing (CMC) · Supplement 58 · priorityAP
1983-11-18Labeling · Supplement 51AP
1983-07-29Manufacturing (CMC) · Supplement 42 · priorityAP
1983-05-11Manufacturing (CMC) · Supplement 54 · priorityAP
1983-01-31Manufacturing (CMC) · Supplement 50 · priorityAP
1983-01-19Manufacturing (CMC) · Supplement 52 · priorityAP
1982-03-03Manufacturing (CMC) · Supplement 46 · 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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