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Details for New Drug Application (NDA): 204507

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NDA 204507 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: 204507

Tradename:
FEXOFENADINE HYDROCHLORIDE ALLERGY
Applicant:
Sciegen Pharms Inc
Ingredient:
fexofenadine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204507

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL 204507 ANDA ScieGen Pharmaceuticals, Inc. 50228-201 50228-201-01 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01)
FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL 204507 ANDA ScieGen Pharmaceuticals, Inc. 50228-201 50228-201-02 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02)

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Sep 16, 2015TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength180MG
Approval Date:Sep 16, 2015TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Sep 16, 2015TE:RLD:No


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