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Generated: May 30, 2017

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Details for New Drug Application (NDA): 076502

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NDA 076502 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-five 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 and four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for NDA: 076502

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076502

Suppliers and Packaging for NDA: 076502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fexofenadine hydrochloride
TABLET;ORAL 076502 ANDA Kaiser Permanente 0179-8325 0179-8325-30 1 BOTTLE in 1 CARTON (0179-8325-30) > 30 TABLET in 1 BOTTLE
fexofenadine hydrochloride
TABLET;ORAL 076502 ANDA Walgreens Company 0363-0784 0363-0784-07 1 BLISTER PACK in 1 CARTON (0363-0784-07) > 5 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 11, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Apr 11, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength180MG
Approval Date:Apr 11, 2006TE:ABRLD:No

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