Data updated: Sep 20, 2026
APRESOLINE (hydralazine hydrochloride) · Novartis
Cardiovascular
Approved 1953-01-15
1
Indication
--
Phase 3 Trials
1
Priority Reviews
73
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1953-01-15
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
APRESOLINE Approval History
1954
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Original
New Indication
New Form
Label Update
205 FDA actions from 1953 to 1999
Apr 1999 SUPPL Priority
Mfg · Manufacturing (CMC)
Feb 1997 SUPPL Priority
Mfg · Manufacturing (CMC)
Aug 1996 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 1994 SUPPL Priority
Mfg
Dec 1993 SUPPL Priority
Mfg
Jan 1992 SUPPL Priority
Mfg
Aug 1991 SUPPL Priority
Mfg
Jun 1991 SUPPL Priority
Mfg
Mar 1989 SUPPL Priority
Label
Dec 1986 SUPPL Priority
Label
Sep 1985 SUPPL Priority
Label
Apr 1985 SUPPL Priority
Label
Mar 1985 SUPPL Priority
Mfg
Sep 1984 SUPPL Priority
Mfg
Dec 1983 SUPPL Priority
Mfg
Nov 1983 SUPPL Priority
Mfg
Jul 1983 SUPPL Priority
Mfg
Aug 1982 SUPPL Priority
Mfg
May 1982 SUPPL Priority
Mfg
Feb 1981 SUPPL Priority
Label
May 1980 SUPPL Priority
Label
Jan 1980 SUPPL Priority
Mfg
Oct 1979 SUPPL Priority
Label
Aug 1979 SUPPL Priority
Mfg
Jul 1979 SUPPL Priority
Mfg
May 1979 SUPPL Priority
Mfg
Apr 1979 SUPPL Priority
Mfg
Dec 1977 SUPPL Priority
Mfg
Sep 1977 SUPPL Priority
Mfg
Jul 1977 SUPPL Priority
Mfg
Apr 1977 SUPPL Priority
Mfg
Apr 1976 SUPPL Priority
Label
Jan 1953 ORIGINAL Priority
New Drug
What APRESOLINE Treats
1 FDA approvalsOriginally approved for its first indication in 1953 .
- Other (1)
Other
(1 approval)- • Approved indication (Jan 1953) Priority
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
TRYPTYR
2025 ACOLTREMON
1 designation
VANRAFIA
2025 ATRASENTAN HYDROCHLORIDE
1 designation
RHAPSIDO
2025 REMIBRUTINIB
1 designation
FABHALTA
2023 IPTACOPAN HYDROCHLORIDE
3 designations
PLUVICTO
2022 LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
4 designations
LEQVIO
2021 INCLISIRAN SODIUM
2 designations
SCEMBLIX
2021 ASCIMINIB HYDROCHLORIDE
5 designations
TABRECTA
2020 CAPMATINIB HYDROCHLORIDE
4 designations
ADAKVEO
2019 CRIZANLIZUMAB-TMCA
4 designations
BEOVU
2019 brolucizumab-dbll
PIQRAY
2019 ALPELISIB
1 designation
EGATEN
2019 TRICLABENDAZOLE
3 designations
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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.
APRESOLINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.