Data updated: Sep 20, 2026
HYDRALAZINE HYDROCHLORIDE · IVAX SUB TEVA PHARMS
Cardiovascular
Approved 1953-01-15
45
Indications
--
Phase 3 Trials
73
Years on Market
Details
- Status
- Prescription
- First Approved
- 1953-01-15
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
IVAX SUB TEVA PHARMS Hikma PLIVA HALSEY Teva HERITAGE CHARTWELL RX STRIDES PHARMA SCIEGEN PHARMS AM REGENT UPSHER SMITH LABS VITARINE STRIDES PHARMA INTL VANGARD TP ANDA HOLDINGS SUPERPHARM ALKEM LABS LTD RISING KINDOS CADILA PHARMS LTD USL PHARMA ASCOT SMITH AND NEPHEW QUANTUM PHARMICS ABRAXIS PHARM INVAGEN PHARMS NAVINTA LLC EUGIA PHARMA HETERO LABS LTD III MUTUAL PHARM IMPAX LABS WATSON LABS PUREPAC PHARM HERITAGE PHARMS INC SOLOPAK GLENMARK PHARMS LTD PHARMOBEDIENT Fresenius Kabi MACLEODS PHARMS Baxter
Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Website: ↗
HYDRALAZINE HYDROCHLORIDE Approval History
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
412 FDA actions from 1974 to 2025
Jul 2025 ORIGINAL
Update
Jun 2025 ORIGINAL
Update
Apr 2025 SUPPL
Label · Labeling
Oct 2024 SUPPL
Label
Aug 2024 ORIGINAL
Update
Oct 2023 SUPPL
Label
Feb 2023 ORIGINAL
Update
Mar 2021 SUPPL
Label
Dec 2020 ORIGINAL
Update
Oct 2018 SUPPL
Label
Jul 2018 ORIGINAL
Update
May 2017 ORIGINAL
Update
Apr 2016 ORIGINAL
Update
Jan 2016 SUPPL
Label
May 2015 SUPPL
Label
Mar 2015 SUPPL
Label
Sep 2014 ORIGINAL
Update
Sep 2014 SUPPL
Mfg
May 2013 ORIGINAL
Update
Mar 2013 ORIGINAL
Update
Mar 2013 ORIGINAL
Update
Jan 2013 SUPPL
Label
Jan 2013 SUPPL
Label
Dec 2012 ORIGINAL
Update
Dec 2010 ORIGINAL
Update
Nov 2010 SUPPL
Label
Oct 2010 SUPPL
Label
Feb 2010 ORIGINAL
Update
Feb 2010 SUPPL
Label
May 2009 ORIGINAL
Update
Apr 2009 ORIGINAL
Update
Dec 2008 ORIGINAL
Update
Sep 2008 ORIGINAL
Update
Dec 2002 SUPPL
Mfg
Dec 2001 SUPPL
Label
Oct 2001 SUPPL
Label
Jun 2001 SUPPL
Mfg
Jun 2001 SUPPL
Mfg
Jun 2001 SUPPL
Mfg
May 2001 SUPPL
Mfg
Apr 2001 SUPPL
Mfg
Oct 2000 SUPPL
Mfg
Jul 2000 SUPPL
Mfg
May 2000 SUPPL
Mfg
Jan 2000 SUPPL
Mfg
Mar 1999 SUPPL
Mfg
Dec 1998 SUPPL
Mfg
Dec 1998 SUPPL
Mfg
Dec 1997 SUPPL
Mfg
Jun 1997 ORIGINAL
Update
Feb 1997 SUPPL
Mfg
Sep 1996 SUPPL
Label
Jul 1996 SUPPL
Mfg
Mar 1996 SUPPL
Label
Jan 1996 SUPPL
Mfg
Jun 1995 SUPPL
Mfg
Jan 1995 SUPPL
Mfg
Dec 1994 SUPPL
Mfg
Oct 1994 SUPPL
Mfg
Sep 1994 ORIGINAL
Update
May 1994 SUPPL
Mfg
Jan 1994 SUPPL
Mfg
Jan 1994 SUPPL
Mfg
Sep 1992 SUPPL
Label
Apr 1992 SUPPL
Mfg
Feb 1992 SUPPL
Mfg
Feb 1992 SUPPL
Label
Aug 1991 SUPPL
Mfg
Jul 1991 SUPPL
Mfg
Feb 1991 SUPPL
Label
Jan 1991 SUPPL
Mfg
Nov 1990 SUPPL
Mfg
Aug 1990 SUPPL
Mfg
Jun 1990 SUPPL
Mfg
Apr 1990 SUPPL
Mfg
Dec 1989 SUPPL
Label
Sep 1989 SUPPL
Label
May 1989 SUPPL
Mfg
Jan 1989 SUPPL
Label
Dec 1988 SUPPL
Label
Nov 1988 SUPPL
Label
Oct 1988 SUPPL
Label
Aug 1988 SUPPL
Mfg
Jul 1988 SUPPL
Label
Apr 1988 SUPPL
Mfg
Mar 1988 SUPPL
Label
Mar 1988 SUPPL
Mfg
Oct 1987 SUPPL
Mfg
Oct 1987 SUPPL
Mfg
May 1987 SUPPL
Mfg
Apr 1987 SUPPL
Mfg
Apr 1987 SUPPL
Mfg
Mar 1987 SUPPL
Mfg
Mar 1987 SUPPL
Mfg
Oct 1986 SUPPL
Mfg
Aug 1986 SUPPL
Mfg
Jul 1986 ORIGINAL
Update
Jul 1986 SUPPL
Mfg
Jul 1986 SUPPL
Mfg
Jun 1986 SUPPL
Mfg
Jun 1986 SUPPL
Mfg
Jun 1986 SUPPL
Mfg
May 1986 SUPPL
Mfg
May 1986 SUPPL
Mfg
May 1986 SUPPL
Mfg
May 1986 ORIGINAL
Update
Apr 1986 SUPPL
Mfg
Feb 1986 SUPPL
Mfg
Dec 1985 ORIGINAL
Update
Nov 1985 SUPPL
Mfg
Nov 1985 SUPPL
Mfg
Aug 1985 SUPPL
Mfg
Aug 1985 SUPPL
Mfg
Aug 1985 SUPPL
Mfg
Jun 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
Apr 1985 ORIGINAL
Update
Mar 1985 SUPPL
Mfg
Mar 1985 SUPPL
Mfg
Mar 1985 SUPPL
Mfg
Mar 1985 SUPPL
Mfg
Feb 1985 ORIGINAL
Update
Aug 1984 ORIGINAL
Update
Jul 1984 SUPPL
Mfg
May 1984 ORIGINAL
Update
Apr 1984 SUPPL
Mfg
Mar 1984 SUPPL
Mfg
Nov 1983 SUPPL
Mfg
Oct 1983 SUPPL
Mfg
Sep 1983 ORIGINAL
Update
Aug 1983 SUPPL
Mfg
Jul 1983 SUPPL
Mfg
Jul 1983 SUPPL
Mfg
Jul 1983 SUPPL
Mfg
Jun 1983 SUPPL
Mfg
Apr 1983 SUPPL
Mfg
Feb 1983 SUPPL
Mfg
Oct 1982 ORIGINAL
Update
Sep 1982 SUPPL
Mfg
Jun 1982 SUPPL
Mfg
Jun 1982 SUPPL
Mfg
May 1982 ORIGINAL
Update
Mar 1982 ORIGINAL
Update
Mar 1982 SUPPL
Mfg
Feb 1980 ORIGINAL
Update
Oct 1978 ORIGINAL
Update
Apr 1977 ORIGINAL
Update
Nov 1976 ORIGINAL
Update
Aug 1976 ORIGINAL
Update
Feb 1976 ORIGINAL
Update
Sep 1975 ORIGINAL
Update
Sep 1975 ORIGINAL
Update
Nov 1974 ORIGINAL
Update
Aug 1974 ORIGINAL
Update
What HYDRALAZINE HYDROCHLORIDE Treats
45 FDA approvalsOriginally approved for its first indication in 1974 . Covers 45 distinct patient populations.
- Other (45)
Other
(45 approvals)- • Approved indication (Aug 1974)
- • Approved indication (Nov 1974)
- • Approved indication (Sep 1975)
- • Approved indication (Sep 1975)
- • Approved indication (Feb 1976)
- • Approved indication (Aug 1976)
- • Approved indication (Nov 1976)
- • Approved indication (Apr 1977)
- • Approved indication (Oct 1978)
- • Approved indication (Feb 1980)
- • Approved indication (Mar 1982)
- • Approved indication (May 1982)
- • Approved indication (Oct 1982)
- • Approved indication (Sep 1983)
- • Approved indication (May 1984)
- • Approved indication (Aug 1984)
- • Approved indication (Feb 1985)
- • Approved indication (Apr 1985)
- • Approved indication (Dec 1985)
- • Approved indication (May 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Sep 1994)
- • Approved indication (Jun 1997)
- • Approved indication (Feb 2000)Letter
- • Approved indication (Mar 2001)Letter
- • Approved indication (Sep 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (Feb 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Dec 2012)
- • Approved indication (Mar 2013)
- • Approved indication (Mar 2013)
- • Approved indication (May 2013)
- • Approved indication (Sep 2014)
- • Approved indication (Jun 2015)Letter
- • Approved indication (Apr 2016)
- • Approved indication (May 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Dec 2020)
- • Approved indication (Feb 2023)
- • Approved indication (Aug 2024)
- • Approved indication (Jun 2025)
- • Approved indication (Jul 2025)
🔬
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.
HYDRALAZINE HYDROCHLORIDE FDA Label Details
Looking for the branded version?
APRESOLINE
Full clinical data, patents, trials, and competitive landscape for hydralazine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.