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DERMATOP E EMOLLIENT

NDA

PREDNICARBATE | N020279 | VALEANT INTERNATIONAL BERMUDA

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Emprise Pharma LLC, on behalf of New Time Pharmaceu... FDA-2020-P-2166 Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co., Ltd., submitted this suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting approval to file an ANDA for Carvedilol bilayered extended-release tablets using Coreg CR capsules as the reference l	Suitability	2020-11-05	Open	Emprise Pharma LLC

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 DMFs2 inactive

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

TAPI NL BVPREDNICARBATE DRUG SUBSTANCE

DMF 170312003

TARO PHARMACEUTICAL INDUSTRIES LTDPREDNICARBATE USP MICRONIZED

DMF 205102007

CHEMAGIS LTDInactivePREDNICARBATE

DMF 164852003

SANOFI AVENTIS DEUTSCHLAND GMBHInactivePREDNICARBATE

DMF 255042011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 10, 2010	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Oct 29, 1993

No patent or exclusivity listings for this strength.