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FDA ANDA · ANDA205811

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA205811
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-19
LATEST ACTION
2025-07-23
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

2025-07-23Labeling · Supplement 10 · standardAP
2020-02-24Labeling · Supplement 2 · standardAP
2016-08-19UNKNOWN · Original · standard — Letter ↗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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