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Details for New Drug Application (NDA): 077081

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NDA 077081 describes FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Sciegen Pharms Inc, Wockhardt Ltd, Teva, Sun Pharm Inds, and Mylan, and is included in six NDAs. It is available from eighty-two suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for NDA: 077081

Tradename:
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
Applicant:
Mylan
Ingredient:
fexofenadine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077081

Suppliers and Packaging for NDA: 077081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL 077081 ANDA Mylan Pharmaceuticals Inc. 0378-0781 0378-0781-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-05)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL 077081 ANDA Mylan Pharmaceuticals Inc. 0378-0781 0378-0781-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength180MG
Approval Date:Apr 16, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 11, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Apr 11, 2008TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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