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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 211301


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NDA 211301 describes URSODIOL, which is a drug marketed by Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Norvium Bioscience, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from twenty-eight suppliers. Additional details are available on the URSODIOL profile page.

The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 211301
Tradename:URSODIOL
Applicant:Amneal Pharms Co
Ingredient:ursodiol
Patents:0
Pharmacology for NDA: 211301
Suppliers and Packaging for NDA: 211301
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol CAPSULE;ORAL 211301 ANDA Major Pharmaceuticals 0904-7168 0904-7168-06 50 BLISTER PACK in 1 CARTON (0904-7168-06) / 1 CAPSULE in 1 BLISTER PACK
URSODIOL ursodiol CAPSULE;ORAL 211301 ANDA Major Pharmaceuticals 0904-7168 0904-7168-61 100 BLISTER PACK in 1 CARTON (0904-7168-61) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Oct 16, 2018TE:ABRLD:No

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