TheraRadar
Data updated: Jun 28, 2026

AMCINONIDE · GENUS

Generic · see CYCLOCORT Corticosteroid Hormone Receptor Agonists
Dermatology Approved 1979-10-18

: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
46
Years on Market

Details

Status
Prescription
First Approved
1979-10-18
Routes
TOPICAL
Dosage Forms
OINTMENT, LOTION, CREAM

Companies

GENUS SOLUBIOMIX GENUS LIFESCIENCES TARO PHARM INDS
Active Ingredient: AMCINONIDE

AMCINONIDE Approval History

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
5 FDA actions from 2002 to 2003
May 2003 ORIGINAL
Update
Mar 2003 ORIGINAL
Update
Nov 2002 ORIGINAL
Update

What AMCINONIDE Treats

1 indications

AMCINONIDE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

AMCINONIDE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

HALOBETASOL PROPIONATE AND TAZAROTENE
SUN PHARMA
2025 1 indic.
CLOCORTOLONE PIVALATE
TARO
2020 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to AMCINONIDE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALA-SCALP
HYDROCORTISONE
1 shared
LEGACY PHARMA
Shared indications:
Dermatoses
ALCLOMETASONE DIPROPIONATE
ALCLOMETASONE DIPROPIONATE
1 shared
GLENMARK PHARMS LTD
Shared indications:
Dermatoses
ANUSOL HC
HYDROCORTISONE
1 shared
SALIX PHARMS
Shared indications:
Dermatoses
View all 20 similar drugs Pro
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

AMCINONIDE FDA Label Details

Indications & Usage

: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Looking for the branded version?

CYCLOCORT

Full clinical data, patents, trials, and competitive landscape for amcinonide.

See CYCLOCORT

Data Sources

FDA Approval: ANDA076096 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.