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FDA ANDA · ANDA207825

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA207825
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-06
LATEST ACTION
2026-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDiscontinued
DOXYLAMINE SUCCINATE 10MG, PYRIDOXINE HYDROCHLORIDE 10MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2026-06-10Labeling · Supplement 1 · standardAP
2020-07-06UNKNOWN · Original · standardAP
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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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