Data updated: Mar 10, 2026
ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE
Approved 1978-12-01
17
Indications
--
Phase 3 Trials
47
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1978-12-01
- Routes
- ORAL, SUBLINGUAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
ANI PHARMS PH HEALTH SUPERPHARM Novartis RUBICON WATSON LABS Sun Pharma IMPAX LABS INC Hikma ZYDUS LIFESCIENCES WATSON LABS TEVA
Active Ingredient: ISOSORBIDE DINITRATE
Website: ↗
ISOSORBIDE DINITRATE Approval History
Loading approval history...
What ISOSORBIDE DINITRATE Treats
17 FDA approvalsOriginally approved for its first indication in 1978 . Covers 17 distinct patient populations.
- Other (17)
Other
(17 approvals)- • Approved indication (Dec 1978)
- • Approved indication (Feb 1987)
- • Approved indication (Mar 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Oct 1987)
- • Approved indication (Nov 1987)
- • Approved indication (Jan 1988)
- • Approved indication (Jan 1988)
- • Approved indication (Feb 1988)
- • Approved indication (Feb 1988)
- • Approved indication (Apr 1988)
- • Approved indication (Dec 1998)Letter
- • Approved indication (Jan 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Nov 2019)
- • Approved indication (Nov 2021)Letter
- • Approved indication (Jul 2022)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
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 DINITRATE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.