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FDA NDA · NDA209661

BONJESTA

doxylamine succinate and pyridoxine hydrochloride

Sponsor: DUCHESNAY

APPLICATION
NDA209661
TYPE
NDA
ORIGINAL APPROVAL
2016-11-07
LATEST ACTION
2022-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

BONJESTA · ReferencePrescription
DOXYLAMINE SUCCINATE 20MG, PYRIDOXINE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-10-31Labeling · Supplement 8 · standard — Letter ↗AP
2022-02-23Manufacturing (CMC) · Supplement 7 · standard — Label ↗AP
2018-06-18Labeling · Supplement 4 · standard — Letter ↗AP
2016-11-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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