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DOVONEX

NDA

CALCIPOTRIENE | N020611 | LEO PHARMACEUTICAL PRODUCTS LTD

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs4 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

LEO PHARMA ASCALCIPOTRIENE HYDRATE DRUG SUBSTANCE

DMF 105141993

LEO PHARMA ASCALCIPOTRIENE CREAM

DMF 105151993

TAPI NL BVCALCIPOTRIENE USP

DMF 169582003

ALP PHARM BEIJING CO LTDCALCIPOTRIENE (CALCIPOTRIOL)

DMF 219432008

CERBIOS PHARMA SACALCIPOTRIENE ANHYDROUS

DMF 231032009

ALP PHARM BEIJING CO LTDCALCIPOTRIENE HYDRATE

DMF 272222013

CERBIOS PHARMA SACALCIPOTRIENE MONOHYDRATE

DMF 306152016

NANJING HERON PHARMACEUTICAL CO LTDCALCIPOTRIENE MONOHYDRATE

DMF 387432023

ANHUI HAOYUAN PHARMACEUTICAL CO LTDCALCIPOTRIENE

DMF 406922024

LEO PHARMA ASInactiveCALCIPOTRIENE DRUG SUBSTANCE

DMF 83081989

LEO PHARMA ASInactiveCALCIPOTRIENE OINTMENT

DMF 83121989

LEO PHARMA ASInactiveCALCIPOTRIENE SCALP SOLUTION

DMF 108391994

SAFC INCInactiveCALCIPOTRIENE

DMF 169282003

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 4, 2007	SUPPL -7	View Letter (PDF)
May 2, 2005	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Mar 3, 1997

No patent or exclusivity listings for this strength.