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FDA NDA · NDA020785

THALOMID

thalidomide

Sponsor: BRISTOL-MYERS

APPLICATION
NDA020785
TYPE
NDA
ORIGINAL APPROVAL
1998-07-16
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

THALOMID · ReferencePrescription
THALIDOMIDE 50MG · CAPSULE · ORAL
THALOMID · ReferencePrescription
THALIDOMIDE 150MG · CAPSULE · ORAL
THALOMID · ReferencePrescription
THALIDOMIDE 100MG · CAPSULE · ORAL
THALOMID · ReferencePrescription
THALIDOMIDE 200MG · CAPSULE · ORAL

Approval history

2026-04-27REMS · Supplement 73LetterAP
2023-03-24REMS · Supplement 71LetterAP
2021-08-05REMS · Supplement 70LetterAP
2021-02-25Labeling · Supplement 69 · standardLetterAP
2019-12-04Labeling · Supplement 68 · standardLetterAP
2019-06-07Labeling · Supplement 67 · standardLetterAP
2017-12-29Labeling · Supplement 65 · standardLetterAP
2017-11-30Labeling · Supplement 64 · standardLabelAP
2017-06-27REMS · Supplement 63LetterAP
2017-01-27Labeling · Supplement 61 · standardLabelAP
2016-04-22REMS · Supplement 60LetterAP
2015-12-01REMS · Supplement 59LetterAP
2015-10-27REMS · Supplement 58LetterAP
2015-09-13REMS · Supplement 57LetterAP
2015-08-05Labeling · Supplement 51 · standardLetterAP
2014-09-12REMS · Supplement 54LetterAP
2014-06-19Labeling · Supplement 55 · standardLetterAP
2013-11-15REMS · Supplement 50LetterAP
2013-02-08REMS · Supplement 48LabelAP
2012-02-03Efficacy · Supplement 40 · standardLabelAP
2012-02-03Labeling · Supplement 43 · unknownLetterAP
2012-02-03Labeling · Supplement 35 · standardLetterAP
2010-08-03Labeling · Supplement 39 · standardLetterAP
2007-01-10Manufacturing (CMC) · Supplement 32LetterAP
2006-05-25Labeling · Supplement 31 · standardLabelAP
2004-03-05Labeling · Supplement 26 · standardLetterAP
2004-03-05Labeling · Supplement 25 · standardLetterAP
2003-10-27Labeling · Supplement 24 · standardLetterAP
2003-10-27Labeling · Supplement 22 · standardLabelAP
2003-10-27Labeling · Supplement 23 · standardLetterAP
2003-01-17Manufacturing (CMC) · Supplement 20 · priorityLabelAP
2003-01-17Labeling · Supplement 21 · standardReviewAP
2001-11-16Manufacturing (CMC) · Supplement 16 · priorityAP
2001-11-16Manufacturing (CMC) · Supplement 17 · priorityAP
2001-11-01Manufacturing (CMC) · Supplement 15 · priorityAP
2001-09-04Labeling · Supplement 14 · standardReviewAP
2001-09-04Labeling · Supplement 12 · standardLabelAP
2000-05-15Manufacturing (CMC) · Supplement 10 · priorityAP
2000-04-03Manufacturing (CMC) · Supplement 11 · priorityAP
1999-10-28Manufacturing (CMC) · Supplement 9 · priorityAP
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