← FDA DRUG APPROVALS

FDA ANDA · ANDA212472

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA212472
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-01
LATEST ACTION
2022-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDiscontinued
DOXYLAMINE SUCCINATE 20MG, PYRIDOXINE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-03-01UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →