FDA ANDA · ANDA078979
DIVALPROEX SODIUM
Sponsor: DR REDDYS LABS LTD
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APPLICATION
ANDA078979
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-23
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2026-10-14Labeling · Supplement 29 · standardAP
2026-10-14Labeling · Supplement 28 · standardAP
2026-10-14Labeling · Supplement 32 · standardAP
2026-10-14Labeling · Supplement 30 · standardAP
2023-10-11Labeling · Supplement 27 · standardAP
2023-01-11Labeling · Supplement 26 · standardAP
2023-01-11Labeling · Supplement 24 · standardAP
2020-07-06Labeling · Supplement 23 · standardAP
2020-01-21Labeling · Supplement 19 · standardAP
2020-01-21Labeling · Supplement 21 · standardAP
2020-01-21Labeling · Supplement 18 · standardAP
2020-01-21Labeling · Supplement 22 · standardAP
2020-01-21Labeling · Supplement 20 · standardAP
2016-05-19Labeling · Supplement 15 · standardAP
2016-05-19Labeling · Supplement 16 · standardAP
2015-08-18Labeling · Supplement 11 · standardAP
2015-08-18Labeling · Supplement 14 · standardAP
2015-08-18Labeling · Supplement 12 · standardAP
2014-11-08Labeling · Supplement 9 · standardAP
2014-11-08Labeling · Supplement 10 · standardAP
2014-02-05Labeling · Supplement 6AP
2014-02-05Labeling · Supplement 7 · standardAP
2014-02-05Labeling · Supplement 8 · standardAP
2011-01-21Labeling · Supplement 4AP
2010-01-07Labeling · Supplement 3AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →