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NDA

CLOBETASOL PROPIONATE | N021142 | PHARMOBEDIENT CONSULTING LLC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Paddock Laboratories FDA-2006-P-0014 Paddock Laboratories, Inc. submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Clobetasol Propionate Foam, 0.05%, suitable for submission in an Abbreviated New Drug Application, with the proposed change being a dosage	Other	2008-05-13	Withdrawn	Paddock Laboratories

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs4 inactive

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

TAPI NL BVCLOBETASOL PROPIONATE

DMF 68141987

FARMABIOS SPACLOBETASOL PROPIONATE

DMF 83361989

SYMBIOTEC PHARMALAB PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 208212007

HALCYON LABS PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 212162008

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDCLOBETASOL PROPIONATE

DMF 240152010

CURIA SPAIN SAUCLOBETASOL PROPIONATE MICRONIZED

DMF 261912012

ENVEE DRUGS PVT LTDCLOBETASOL PROPIONATE USP

DMF 307522016

RN LABORATORIES EUROPE BVCLOBETASOL PROPIONATE USP (21-CHLORO-9-FLUORO-11, 17-DIHYDROXY-16-METHYLPREGNA-1,4-DIENE3,20-DIONE 17-PROPIONATE)

DMF 344852020

NEWCHEM SPACLOBETASOL PROPIONATE

DMF 428922025

CESQUISA SAInactiveCLOBETASOL PROPIONATE

DMF 80961989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCLOBETASOL PROPIONATE

DMF 182022005

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveCLOBETASOL PROPIONATE USP

DMF 226502008

GLAXOSMITHKLINE LLCInactiveCLOBETASOL PROPIONATE

DMF 254442012

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2018	SUPPL -22	View Letter (PDF)
Apr 24, 2014	SUPPL -19	View Letter (PDF)
Jul 21, 2006	SUPPL -12	View Letter (PDF)
Jan 2, 2004	SUPPL -10	View Letter (PDF)
Nov 25, 2003	SUPPL -9	View Letter (PDF)
Jul 28, 2003	SUPPL -7	View Letter (PDF)
Dec 20, 2002	SUPPL -4	View Letter (PDF)
Mar 29, 2002	SUPPL -3	View Letter (PDF)
May 26, 2000	ORIG -1	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▴

AEROSOL, FOAM;TOPICAL | Approved: May 26, 2000

No patent or exclusivity listings for this strength.