Data updated: Mar 10, 2026
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE
Approved 1992-11-05
52
Indications
--
Phase 3 Trials
33
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1992-11-05
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, INJECTABLE, TABLET, EXTENDED RELEASE, TABLET
Companies
PH HEALTH Dr. Reddy's RISING INTL MEDICATION Teva CHARTWELL RX EUGIA PHARMA Viatris PHARMOBEDIENT ALEMBIC Pfizer NOVAST LABS GLENMARK PHARMS LTD SCIEGEN PHARMS Sun Pharma UTOPIC PHARMS BIOVAIL VALEANT PHARMS NORTH NESHER PHARMS Hikma ZYDUS PHARMS ACCORD HLTHCARE APOTHECON IVAX SUB TEVA PHARMS SAGENT TWI PHARMS AMTA EDENBRIDGE PHARMS CHARTWELL MOLECULES Apotex ZYDUS LIFESCIENCES
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Website: ↗
DILTIAZEM HYDROCHLORIDE Approval History
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What DILTIAZEM HYDROCHLORIDE Treats
52 FDA approvalsOriginally approved for its first indication in 1992 . Covers 52 distinct patient populations.
- Other (52)
Other
(52 approvals)- • Approved indication (Nov 1992)
- • Approved indication (Mar 1993)
- • Approved indication (Nov 1993)
- • Approved indication (Mar 1995)
- • Approved indication (May 1995)
- • Approved indication (Feb 1996)
- • Approved indication (May 1997)
- • Approved indication (Aug 1997)
- • Approved indication (Oct 1997)
- • Approved indication (Mar 1998)Label Letter
- • Approved indication (Apr 1998)Label Letter
- • Approved indication (Apr 1998)Label Letter
- • Approved indication (Aug 1998)Label Letter
- • Approved indication (Apr 1999)Letter
- • Approved indication (Sep 1999)Label Letter
- • Approved indication (Sep 1999)Letter
- • Approved indication (Dec 1999)Letter
- • Approved indication (Dec 1999)Letter
- • Approved indication (Jan 2000)Label Letter
- • Approved indication (Feb 2000)Letter
- • Approved indication (Nov 2001)Letter
- • Approved indication (Dec 2002)
- • Approved indication (Sep 2006)Letter
- • Approved indication (Dec 2008)
- • Approved indication (Mar 2010)
- • Approved indication (Nov 2010)
- • Approved indication (Oct 2011)
- • Approved indication (Aug 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Jun 2017)
- • Approved indication (Aug 2017)Letter
- • Approved indication (Aug 2017)Letter
- • Approved indication (May 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Jun 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Apr 2020)
- • Approved indication (Mar 2021)Letter
- • Approved indication (May 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Mar 2023)
- • Approved indication (Mar 2023)
- • Approved indication (Apr 2023)
- • Approved indication (Oct 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Mar 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Aug 2025) New
- • Approved indication (Nov 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
DILTIAZEM HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.