Viewing data from:

ARISTOSPAN

NDA

TRIAMCINOLONE HEXACETONIDE | N016466 | ETHYPHARM INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Medexus Pharma, Inc. FDA-2022-P-1168 Medexus Pharma, Inc. filed a suitability petition under 21 CFR 10.20, 10.30, and 314.93 requesting that the FDA determine that a 2 mL fill volume for triamcinolone hexacetonide injectable suspension, 20 mg/mL (total strength 40 mg per vial) is suitable for ANDA submission to address a drug shortage,	Suitability	2022-06-16	Open	Medexus Pharma
Citizen Petition from Medexus Pharma Inc FDA-2022-P-1104 Medexus Pharma Inc. filed this citizen petition requesting that the FDA determine whether ARISTOSPAN (triamcinolone hexacetonide injectable suspension, USP), 20 mg/mL, NDA 016466, held by Sandoz Inc., was voluntarily withdrawn from commercial sale for safety or effectiveness reasons, as required und	505(q)	2022-06-13	Withdrawn	Medexus Pharma Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

8 trials from ClinicalTrials.gov — 5 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain NCT07568015	N/A	Not Yet Recruiting	Brixton Biosciences, Inc.	100	2026-07-01 → 2029-11-01
Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment NCT07666620	Phase 4	Not Yet Recruiting	Noor Aziz	50	2026-10-01 → 2027-04-30
CO2 LADD TAC With and Without 5-FU for Hypertrophic Burn Scars: A Triple-Blinded, Split Scar RCT NCT07660120	N/A	Not Yet Recruiting	University of California, Davis	65	2026-07-01 → 2028-07-10
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)NCT06504160	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	86	2025-05-22 → 2027-02-05
TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus NCT06748404	Phase 2	Recruiting	University of California, San Diego	28	2025-03-05 → 2028-12
Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers NCT07672730	Phase 4	Completed	Cairo University	42	2026-02-20 → 2026-04-20
Comparison of the Effects Suprascapular Nerve Block and Intra-articular Shoulder Injection NCT05909462	N/A	Completed	Hitit University	60	2023-01-21 → 2023-05-24
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)NCT05478902	N/A	Suspended	University of Valencia	116	2028-01-01 → 2029-12-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

FARMABIOS SPATRIAMCINOLONE HEXACETONIDE

DMF 177582004

CORAL DRUGS PRIVATE LTDTRIAMCINOLONE HEXACETONIDE

DMF 373462022

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveTRIAMCINOLONE HEXACETONIDE

DMF 69581987

QUATRUMInactiveTRIAMCINOLONE HEXACETONIDE

DMF 72551987

ROUSSELL UCLAFInactiveTRIAMCINOLONE HEXACETONIDE

DMF 83291989

BRISTOL MYERS SQUIBB COInactiveTRIAMCINOLONE HEXACETONIDE

DMF 98471992

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982