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FLORONE E

NDA

DIFLORASONE DIACETATE | N019259 | PFIZER 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Kirkpatrick & Lockhart Nicholson Graham LLP FDA-2006-P-0144 · 9 docket documents Kirkpatrick & Lockhart Nicholson Graham LLP filed this citizen petition on behalf of an unnamed client pursuant to section 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA determine that Psorcone E (diflorasone diacetate ointment) Emollient Ointment, 0.05%, was voluntarily	505(q)	2008-11-19	Withdrawn	Kirkpatrick & Lockhart Nicholson Graham LLP

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

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 30, 2017	SUPPL -12	View Letter (PDF)
Jun 8, 2003	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Aug 28, 1985

No patent or exclusivity listings for this strength.