APPLICATION
ANDA070651
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-05
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 19 · standardAP
2024-11-19Labeling · Supplement 18 · standardAP
2021-04-28Labeling · Supplement 16 · standardAP
2021-04-26Labeling · Supplement 15 · standardAP
2016-05-09Labeling · Supplement 14 · standardAP
1996-07-26Labeling · Supplement 13AP
1996-06-07Manufacturing (CMC) · Supplement 12AP
1991-09-10Labeling · Supplement 11AP
1991-07-16Labeling · Supplement 10AP
1989-05-02Manufacturing (CMC) · Supplement 6AP
1989-05-02Labeling · Supplement 9AP
1989-02-02Labeling · Supplement 8AP
1988-10-26Labeling · Supplement 7AP
1987-03-24Labeling · Supplement 2AP
1986-10-27Manufacturing (CMC) · Supplement 4AP
1986-09-15Labeling · Supplement 3AP
1986-03-21Labeling · Supplement 1AP
1986-03-05OriginalAP
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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