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FDA ANDA · ANDA070267

INDO-LEMMON

Sponsor: TEVA

APPLICATION
ANDA070267
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-07
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

INDO-LEMMONDiscontinued
INDOMETHACIN 50MG · CAPSULE · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 27AP
1995-10-03Manufacturing (CMC) · Supplement 25AP
1995-10-03Manufacturing (CMC) · Supplement 26AP
1995-10-03Manufacturing (CMC) · Supplement 24AP
1995-03-02Manufacturing (CMC) · Supplement 23AP
1994-01-26Manufacturing (CMC) · Supplement 19AP
1994-01-26Manufacturing (CMC) · Supplement 17AP
1994-01-26Manufacturing (CMC) · Supplement 21AP
1994-01-26Manufacturing (CMC) · Supplement 18AP
1994-01-26Manufacturing (CMC) · Supplement 22AP
1994-01-26Manufacturing (CMC) · Supplement 20AP
1993-04-01Manufacturing (CMC) · Supplement 15AP
1993-04-01Manufacturing (CMC) · Supplement 16AP
1993-04-01Manufacturing (CMC) · Supplement 14AP
1991-09-10Labeling · Supplement 13AP
1990-03-23Labeling · Supplement 10AP
1990-03-23Manufacturing (CMC) · Supplement 9AP
1989-06-30Labeling · Supplement 12AP
1989-02-22Labeling · Supplement 11AP
1988-04-22Manufacturing (CMC) · Supplement 7AP
1987-07-17Manufacturing (CMC) · Supplement 4AP
1987-07-17Manufacturing (CMC) · Supplement 5AP
1987-07-17Manufacturing (CMC) · Supplement 3AP
1985-11-07OriginalAP
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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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