APPLICATION
ANDA073314
TYPE
ANDA
ORIGINAL APPROVAL
1992-08-31
LATEST ACTION
2024-11-21
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 50MG · SUPPOSITORY · RECTAL
Approval history
2024-11-21Labeling · Supplement 29 · standardAP
2021-04-28Labeling · Supplement 25 · standardAP
2019-09-11Labeling · Supplement 23 · standardAP
2019-09-11Labeling · Supplement 22 · standardAP
2016-05-09Labeling · Supplement 16 · standardAP
2011-04-29Labeling · Supplement 12AP
2006-03-13Labeling · Supplement 7AP
1997-01-28Manufacturing (CMC) · Supplement 3AP
1993-03-04Labeling · Supplement 1AP
1992-08-31OriginalAP
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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