← FDA DRUG APPROVALS

FDA ANDA · ANDA075361

ISOSORBIDE MONONITRATE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA075361
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-05
LATEST ACTION
2000-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 20MG · TABLET · ORAL

Approval history

2000-10-05OriginalLetterAP
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 →