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Last Updated: November 4, 2024

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 Aurobindo Pharma, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharm, and is included in seven NDAs. It is available from twenty-seven 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Pharmacology for NDA: 076667
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 0363-1606 0363-1606-20 4 BLISTER PACK in 1 CARTON (0363-1606-20) / 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 0363-1606 0363-1606-30 6 BLISTER PACK in 1 CARTON (0363-1606-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile 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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