Data updated: Jun 17, 2026
WESTCORT (hydrocortisone valerate)
Dermatology
Approved 1978-03-17
2
Indications
--
Phase 3 Trials
48
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1978-03-17
- Routes
- TOPICAL
- Dosage Forms
- CREAM, OINTMENT
WESTCORT Approval History
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
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2007
2008
2009
2010
2011
2012
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2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
28 FDA actions from 1978 to 2003
Feb 1993 SUPPL
Mfg · Manufacturing (CMC)
Dec 1991 SUPPL
Mfg
Nov 1991 SUPPL
Mfg
Oct 1988 SUPPL
Mfg
Aug 1986 SUPPL
Mfg
Aug 1985 SUPPL
Mfg
Jan 1985 SUPPL
Mfg
Aug 1984 SUPPL
Mfg
Jun 1984 SUPPL
Mfg
Feb 1984 SUPPL
Mfg
Oct 1983 SUPPL
Mfg
Aug 1983 ORIGINAL
New Form
May 1983 SUPPL
Mfg
Jan 1983 SUPPL
Label
Sep 1982 SUPPL
Mfg
Aug 1981 SUPPL
Mfg
May 1980 SUPPL
Mfg
Mar 1980 SUPPL
Mfg
Jan 1980 SUPPL
Mfg
Jul 1979 SUPPL
Label
Apr 1979 SUPPL
Mfg
Dec 1978 SUPPL
Mfg
Mar 1978 ORIGINAL
New Ingredient
What WESTCORT Treats
2 FDA approvalsOriginally approved for its first indication in 1978 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Mar 1978)
- • Approved indication (Aug 1983)
Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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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.
WESTCORT FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.