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FDA ANDA · ANDA217000

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Sponsor: BIONPHARMA

APPLICATION
ANDA217000
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-04
LATEST ACTION
2023-08-04
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

2023-08-04UNKNOWN · 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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