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NDA

FEXOFENADINE HYDROCHLORIDE | N020625 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

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 Lupin Pharmaceuticals, Inc. FDA-2006-P-0458 Lupin Pharmaceuticals, Inc. filed this suitability petition on September 28, 2006 pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93, requesting that the FDA declare Fexofenadine Hydrochloride for Oral Suspension in 30 mg/5 mL and 60 mg/5 mL strengths suita	Other	2008-07-22	Withdrawn	Lupin Pharmaceuticals

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain16 active DMFs7 inactive

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

DR REDDYS LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE

DMF 157572001

DIPHARMA FRANCIS SRLFEXOFENADINE HYDROCHLORIDE USP

DMF 160292002

WOCKHARDT LTDFEXOFENADINE HYDROCHLORIDE

DMF 198162006

MATRIX PHARMACORP PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 223682008

SYNTHIMED LABS PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 245972011

HETERO DRUGS LTDFEXOFENADINE HYDROCHLORIDE

DMF 256372011

JUBILANT PHARMOVA LTDFEXOFENADINE HYDROCHLORIDE

DMF 267182013

DIPHARMA FRANCIS SRLFEXOFENADINE HYDROCHLORIDE USP FORM A

DMF 282872014

DIPHARMA FRANCIS SRLFEXOFENADINE HYDROCHLORIDE USP FORM l

DMF 286122014

APITORIA PHARMA PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 289952015

PERRIGO API LTDFEXOFENADINE HYDROCHLORIDE

DMF 294452015

VASUDHA PHARMA CHEM LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 297402015

MOREPEN LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 306922016

DR REDDYS LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE USP (FORM-I)

DMF 346452020

THINQ PHARMA-CRO LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 362552021

CHEMECA DRUGS PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 365542021

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 154192001

FARMHISPANIA SAInactiveFEXOFENADINE HYDROCHLORIDE

DMF 155212001

WOCKHARDT LTDInactiveFEXOFENADINE HYDROCHLORIDE

DMF 159772002

CIPLA LTDInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 188002005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveFEXOFENADINE HYDROCHLORIDE

DMF 189492005

SANOFI AVENTIS DEUTSCHLAND GMBHInactiveFEXOFENADINE HYDROCHLORIDE (MDL 16455 A)

DMF 233602009

RA CHEM PHARMA LTDInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 297352015

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 8, 2003	SUPPL -10	View Letter (PDF)
Jun 8, 2003	SUPPL -12	View Letter (PDF)
Jul 11, 2001	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 25, 1996

No patent or exclusivity listings for this strength.