TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ISOSORBIDE MONONITRATE

ISOSORBIDE MONONITRATE
Approved 1998-09-22
Jump to: Indications Approvals Trials Competitors Safety Patents
18
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
Discontinued
First Approved
1998-09-22
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET

Companies

STRIDES PHARMA INTL ANI PHARMS Hikma RICONPHARMA LLC ZYDUS PHARMS TORRENT PHARMS GENUS Teva ACCORD HLTHCARE SHANDONG Aurobindo Pharma DEXCEL LTD SKYEPHARMA AG CHARTWELL MOLECULAR IVAX SUB TEVA PHARMS ZYDUS HLTHCARE ALKERMES GAINESVILLE
Active Ingredient: ISOSORBIDE MONONITRATE

ISOSORBIDE MONONITRATE Approval History

Loading approval history...

What ISOSORBIDE MONONITRATE Treats

18 FDA approvals

Originally approved for its first indication in 1998 . Covers 18 distinct patient populations.

  • Other (18)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ISOSORBIDE MONONITRATE FDA Label Details

Pro

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: ANDA090598 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.