← FDA DRUG APPROVALS
FDA ANDA · ANDA208518
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
doxylamine succinate and pyridoxine hydrochloride, delayed release tablets 10 mg/10 mg
Sponsor: PH HEALTH
APPLICATION
ANDA208518
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-06
LATEST ACTION
2020-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEPrescription
DOXYLAMINE SUCCINATE 10MG, PYRIDOXINE HYDROCHLORIDE 10MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2020-02-24Labeling · Supplement 1 · standardAP
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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