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FDA ANDA · ANDA076941

DIVALPROEX SODIUM

Sponsor: TEVA

APPLICATION
ANDA076941
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2020-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL

Approval history

2020-10-13Labeling · Supplement 19 · standardAP
2020-10-13Labeling · Supplement 25 · standardAP
2020-10-13Labeling · Supplement 17 · standardAP
2020-10-13Labeling · Supplement 23 · standardAP
2020-10-13Labeling · Supplement 21 · standardAP
2020-10-13Labeling · Supplement 20 · standardAP
2016-02-20Labeling · Supplement 15 · standardAP
2016-02-20Labeling · Supplement 13 · standardAP
2016-02-20Labeling · Supplement 16 · standardAP
2016-02-20Labeling · Supplement 14 · standardAP
2016-02-20Labeling · Supplement 12 · standardAP
2014-09-13Labeling · Supplement 9 · standardAP
2014-09-13Labeling · Supplement 7 · standardAP
2014-09-13Labeling · Supplement 5AP
2014-09-13Labeling · Supplement 11 · standardAP
2014-09-13Labeling · Supplement 8 · standardAP
2010-01-20Labeling · Supplement 3AP
2008-07-29OriginalLabelAP
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