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Serving leading biopharmaceutical companies globally:

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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076667

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NDA 076667 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. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for NDA: 076667

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076667

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 076667 ANDA Walgreens Company 0363-0448 0363-0448-14 4 BLISTER PACK in 1 CARTON (0363-0448-14) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 076667 ANDA Walgreens Company 0363-0448 0363-0448-31 6 BLISTER PACK in 1 CARTON (0363-0448-31) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;120MG
Approval Date:Nov 18, 2014TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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QuintilesIMS
Moodys
Daiichi Sankyo
Johnson and Johnson
Chubb
AstraZeneca
Fish and Richardson
Covington

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