Data updated: Sep 20, 2026
ISOPROTERENOL HYDROCHLORIDE · PARKE DAVIS
Cardiovascular
Approved 1948-02-19
22
Indications
--
Phase 3 Trials
78
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1948-02-19
- Routes
- INHALATION, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE, AEROSOL, METERED
Companies
PARKE DAVIS J MOLNER INTL MEDICATION ARMOUR PHARM Cipla AMNEAL Hikma PENN LIFE Pfizer AMPHASTAR PHARMS INC DEVA HOLDING AS SOMERSET THERAPS LLC AM REGENT ASPIRO ABRAXIS PHARM MICRO LABS GLAND ALPHARMA US PHARMS DEY EUGIA PHARMA PHARMOBEDIENT Baxter 3M NEXUS AVET LIFESCIENCES ZYDUS PHARMS
Active Ingredient: ISOPROTERENOL HYDROCHLORIDE
Website: ↗
ISOPROTERENOL HYDROCHLORIDE Approval History
1957
1958
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1960
1961
1962
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2026
Original
New Indication
New Form
Label Update
83 FDA actions from 1956 to 2026
Aug 2026 SUPPL
Label · Labeling
May 2026 ORIGINAL
Update
Dec 2025 ORIGINAL
Update
Oct 2024 ORIGINAL
Update
Aug 2024 SUPPL
Label
Aug 2024 ORIGINAL
Update
Sep 2023 SUPPL
Label
Sep 2023 SUPPL
Label
Apr 2023 ORIGINAL
Update
Apr 2023 ORIGINAL
Update
Oct 2022 ORIGINAL
Update
Sep 2022 ORIGINAL
Update
Sep 2022 ORIGINAL
Update
Nov 2021 ORIGINAL
Update
May 2021 ORIGINAL
Update
Feb 2021 ORIGINAL
Update
Feb 2021 ORIGINAL
Update
Jun 2019 ORIGINAL
Update
Oct 2018 ORIGINAL
Update
Jun 2018 ORIGINAL
Update
Jun 2018 ORIGINAL
Update
Aug 2017 ORIGINAL
Update
Mar 2009 SUPPL
Label
Jun 2002 SUPPL
Mfg
Mar 2000 SUPPL
Label
Nov 1998 SUPPL
Mfg
Jul 1998 SUPPL
Label
Dec 1997 SUPPL
Label
Feb 1997 SUPPL
Label
Jan 1997 SUPPL
Label
Sep 1996 SUPPL
Label
Sep 1995 SUPPL
Mfg
Feb 1995 SUPPL
Mfg
Jun 1994 SUPPL
Mfg
Dec 1993 SUPPL
Mfg
Oct 1993 SUPPL
Mfg
Jun 1992 SUPPL
Label
Jan 1992 SUPPL
Mfg
Dec 1991 SUPPL
Label
Feb 1991 SUPPL
Mfg
Apr 1990 SUPPL
Mfg
Jul 1989 SUPPL
Mfg
May 1989 SUPPL
Label
Mar 1989 SUPPL
Label
Jul 1988 SUPPL
Label
Jun 1988 SUPPL
Label
Apr 1988 SUPPL
Mfg
Dec 1987 SUPPL
Label
Apr 1987 SUPPL
Mfg
Feb 1987 SUPPL
Label
Jun 1986 SUPPL
Mfg
Feb 1986 SUPPL
Mfg
Sep 1985 SUPPL
Mfg
Apr 1984 SUPPL
Mfg
Jan 1984 SUPPL
Mfg
Mar 1983 SUPPL
Mfg
Oct 1982 SUPPL
Mfg
May 1982 SUPPL
Mfg
Mar 1982 SUPPL
Mfg
Sep 1978 SUPPL
Mfg
Apr 1978 SUPPL
Mfg
Nov 1976 SUPPL
Label
Jan 1976 ORIGINAL
Update
Jul 1975 SUPPL
Mfg
Jul 1975 SUPPL
Mfg
Jul 1975 ORIGINAL
Update
Nov 1974 ORIGINAL
Update
Mar 1956 ORIGINAL
New Ingredient
What ISOPROTERENOL HYDROCHLORIDE Treats
22 FDA approvalsOriginally approved for its first indication in 1956 . Covers 22 distinct patient populations.
- Other (22)
Other
(22 approvals)- • Approved indication (Mar 1956)
- • Approved indication (Nov 1974)
- • Approved indication (Jul 1975)
- • Approved indication (Jan 1976)
- • Approved indication (Aug 2017)
- • Approved indication (Jun 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Jun 2019)
- • Approved indication (Feb 2021)
- • Approved indication (Feb 2021)
- • Approved indication (May 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Sep 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Apr 2023)
- • Approved indication (Apr 2023)
- • Approved indication (Aug 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Dec 2025) New
- • Approved indication (May 2026) New
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
🔬
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.
ISOPROTERENOL 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.