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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 213466


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NDA 213466 describes FEXOFENADINE HYDROCHLORIDE, which is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Sciegen Pharms Inc, Sun Pharm Inds, Unique, Wockhardt, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in twenty-two NDAs. It is available from thirty-eight suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE profile page.

The generic ingredient in FEXOFENADINE 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.
Summary for 213466
Pharmacology for NDA: 213466
Suppliers and Packaging for NDA: 213466
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride SUSPENSION;ORAL 213466 ANDA Aurohealth LLC 58602-426 58602-426-20 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE
FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride SUSPENSION;ORAL 213466 ANDA Aurohealth LLC 58602-426 58602-426-24 1 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:May 23, 2023TE:RLD:No

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