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TOPICORT

NDA

DESOXIMETASONE | N018586 | TARO PHARMACEUTICAL INDUSTRIES 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

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 Chain5 active DMFs2 inactive

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

TARO PHARMACEUTICAL INDUSTRIES LTDDESOXIMETASONE USP

DMF 138611998

EUROAPI FRANCEDESOXIMETASONE USP, MICRONIZED

DMF 148522000

FARMABIOS SPADESOXIMETASONE

DMF 177592004

SYMBIOTEC PHARMALAB PRIVATE LTDDESOXIMETASONE USP (MICRONIZED)

DMF 224002009

TARO PHARMACEUTICAL INDUSTRIES LTDDESOXIMETASONE USP, MICRONIZED

DMF 268412013

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDESOXIMETASONE

DMF 74241988

TARO PHARMACEUTICAL INDUSTRIES LTDInactiveDESOXIMETASONE

DMF 110181994

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 29, 2004	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Mar 29, 1982

No patent or exclusivity listings for this strength.