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FDA NDA · NDA021876

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Sponsor: DUCHESNAY

APPLICATION
NDA021876
TYPE
NDA
ORIGINAL APPROVAL
2013-04-08
LATEST ACTION
2022-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

DICLEGIS · ReferencePrescription
DOXYLAMINE SUCCINATE 10MG, PYRIDOXINE HYDROCHLORIDE 10MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2022-10-31Labeling · Supplement 16 · standard — Letter ↗AP
2018-06-18Labeling · Supplement 13 · standard — Letter ↗AP
2016-03-10Manufacturing (CMC) · Supplement 9 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 8 · standardAP
2015-06-23Manufacturing (CMC) · Supplement 7 · standardAP
2014-12-16Labeling · Supplement 6 · standard — Letter ↗AP
2014-11-24Manufacturing (CMC) · Supplement 5 · standardAP
2014-07-30Manufacturing (CMC) · Supplement 4 · standardAP
2014-03-28Manufacturing (CMC) · Supplement 3 · standardAP
2014-01-29Manufacturing (CMC) · Supplement 1 · standardAP
2013-09-30Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2013-04-08Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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