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Details for New Drug Application (NDA): 079043

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NDA 079043 describes FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Global, Barr, Dr Reddys Labs Ltd, and Impax Pharms, and is included in five NDAs. It is available from nine suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Pharmacology for NDA: 079043

Suppliers and Packaging for NDA: 079043

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079043 ANDA Safeway Inc 21130-557 21130-557-35 2 BLISTER PACK in 1 CARTON (21130-557-35) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079043 ANDA Dr.Reddy's Laboratories Limited 55111-557 55111-557-07 1 BLISTER PACK in 1 CARTON (55111-557-07) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG;240MG
Approval Date:Jun 22, 2011TE:RLD:No


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