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FDA NDA · NDA018185

INDOCIN SR

Sponsor: ZYLA

APPLICATION
NDA018185
TYPE
NDA
ORIGINAL APPROVAL
1982-02-23
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

INDOCIN SR · ReferenceDiscontinued
INDOMETHACIN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 59 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 58 · standard — Letter ↗AP
2019-03-26Labeling · Supplement 57 · standard — Label ↗AP
2016-05-09Labeling · Supplement 56 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 55 · standard — Label ↗AP
2001-10-31Labeling · Supplement 48 · standardAP
2001-10-11Labeling · Supplement 53 · standardAP
1997-10-07Manufacturing (CMC) · Supplement 50 · standardAP
1996-03-01Manufacturing (CMC) · Supplement 49 · standardAP
1994-12-30Manufacturing (CMC) · Supplement 43 · standardAP
1994-10-24Labeling · Supplement 47 · standardAP
1994-09-26Labeling · Supplement 41 · standardAP
1994-09-14Labeling · Supplement 42 · standardAP
1994-09-14Labeling · Supplement 45 · standardAP
1994-09-13Labeling · Supplement 46 · standardAP
1994-08-18Manufacturing (CMC) · Supplement 44 · standardAP
1989-05-25Labeling · Supplement 38AP
1989-02-10Labeling · Supplement 31AP
1989-01-09Labeling · Supplement 35AP
1989-01-06Labeling · Supplement 37AP
1989-01-06Labeling · Supplement 33AP
1988-06-03Labeling · Supplement 30AP
1988-03-10Manufacturing (CMC) · Supplement 34 · standardAP
1986-09-19Labeling · Supplement 26AP
1986-08-15Labeling · Supplement 24AP
1986-01-06Labeling · Supplement 11AP
1985-09-30Manufacturing (CMC) · Supplement 20 · standardAP
1985-07-23Labeling · Supplement 22AP
1985-02-21Manufacturing (CMC) · Supplement 18 · standardAP
1985-02-21Manufacturing (CMC) · Supplement 19 · standardAP
1984-11-27Labeling · Supplement 15AP
1984-11-27Labeling · Supplement 21AP
1984-11-20Manufacturing (CMC) · Supplement 17 · standardAP
1984-10-05Manufacturing (CMC) · Supplement 7 · standardAP
1984-10-03Manufacturing (CMC) · Supplement 16 · standardAP
1984-06-25Manufacturing (CMC) · Supplement 13 · standardAP
1984-05-03Manufacturing (CMC) · Supplement 14 · standardAP
1983-10-31Labeling · Supplement 8AP
1983-02-01Labeling · Supplement 6AP
1983-02-01Manufacturing (CMC) · Supplement 2 · standardAP
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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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