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Last Updated: December 13, 2019

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Details for New Drug Application (NDA): 210137

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NDA 210137 describes FEXOFENADINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Teva, Unique Pharm Labs, and Wockhardt Ltd, and is included in nine NDAs. It is available from one hundred and six suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE ALLERGY is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and twelve suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 210137
Tradename:FEXOFENADINE HYDROCHLORIDE ALLERGY
Applicant:Unique Pharm Labs
Ingredient:fexofenadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 210137
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 210137 ANDA Spirit Pharmaceuticals LLC 68210-0122 68210-0122-1 100 TABLET in 1 BOTTLE (68210-0122-1)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength180MG
Approval Date:Aug 13, 2018TE:RLD:No

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