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Details for Generic Name: fexofenadine hydrochloride

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Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Sanofi Aventis Us, Barr, Actavis Mid Atlantic, Dr Reddys Labs Ltd, Mylan, Sun Pharm Inds, Teva, Wockhardt Ltd, and Impax Pharms, and is included in nineteen NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for fexofenadine hydrochloride. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: fexofenadine hydrochloride

Tradenames:13
Patents:16
Applicants:9
NDAs:19
Drug Master File Entries: see list15
Suppliers: see list4
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: fexofenadine hydrochloride

Tentative approvals for FEXOFENADINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60/120MG
<disabled><disabled>TABLET; ORAL30MG
<disabled><disabled>TABLET; ORAL60MG

Clinical Trials for: fexofenadine hydrochloride

Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Status: Completed Condition: Healthy

Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373Jan 24, 2011OTCYes6,037,353*PED<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909Jan 24, 2011OTCYes6,723,348<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872Jan 24, 2011OTCNo5,855,912*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872Jan 24, 2011OTCYes5,578,610*PED<disabled>Y<disabled>
Dr Reddys Labs Ltd
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride
TABLET;ORAL076502Apr 11, 2006RXNo<disabled><disabled>
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