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NDA

TRIAMCINOLONE DIACETATE | N012802 | FOSUN PHARMA USA INC

1 strength0 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from West-ward Pharmaceutical Corp FDA-2006-P-0215 West-ward Pharmaceutical Corp filed this petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA Commissioner determine whether Triamcinolone Diacetate Suspension 40 mg/mL (NDA 012802), originally manufactured by Sandoz, was voluntarily withdrawn from distribution for safety or effectivenes	Other	2009-04-09	Open	West-ward Pharmaceutical Corp

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF4 inactive

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

FARMABIOS SPATRIAMCINOLONE DIACETATE

DMF 175612004

ANTIBIOTICOS SPAInactiveTRIAMCINOLONE DIACETATE

DMF 22071973

BLASCHIM SPAInactiveTRIAMCINOLONE DIACETATE

DMF 28511977

DIOSYNTH BVInactiveTRIAMCINOLONE DIACETATE

DMF 42071981

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveTRIAMCINOLONE DIACETATE

DMF 47181982

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.