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Last Updated: July 10, 2020

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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, Granules India Ltd, Hetero Labs Ltd V, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Teva, Unique Pharm Labs, and Wockhardt Ltd, and is included in ten NDAs. It is available from ninety-eight 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 two suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 210137
Applicant:Unique Pharm Labs
Ingredient:fexofenadine hydrochloride
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)
FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 210137 ANDA Spirit Pharmaceuticals LLC 68210-1220 68210-1220-1 1 BLISTER PACK in 1 BLISTER PACK (68210-1220-1) > 4 TABLET in 1 BLISTER PACK

Profile for product number 001

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

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