← FDA DRUG APPROVALS

FDA ANDA · ANDA212589

QUINIDINE GLUCONATE

quinidine gluonate

Sponsor: HIBROW HLTHCARE

APPLICATION
ANDA212589
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-17
LATEST ACTION
2023-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QUINIDINE GLUCONATEPrescription
QUINIDINE GLUCONATE 324MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-01-27Manufacturing (CMC) · Supplement 2 · unknownAP
2021-09-17UNKNOWN · 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 →