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PSORCON

NDA

DIFLORASONE DIACETATE | N020205 | TARO PHARMACEUTICALS NORTH AMERICA 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs1 inactive

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

TAPI NL BVDIFLORASONE DIACETATE BULK DRUG

DMF 126071997

TARO PHARMACEUTICAL INDUSTRIES LTDDIFLORASONE DIACETATE USP MICRONIZED

DMF 158622002

PHARMACIA AND UPJOHNInactiveDIFLORASONE DIACETATE

DMF 57871985

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

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Nov 20, 1992

No patent or exclusivity listings for this strength.