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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205789


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NDA 205789 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 205789
Tradename:URSODIOL
Applicant:Lgm Pharma
Ingredient:ursodiol
Patents:0
Pharmacology for NDA: 205789
Suppliers and Packaging for NDA: 205789
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol CAPSULE;ORAL 205789 ANDA FH2 Pharma LLC 72887-143 72887-143-06 60 CAPSULE in 1 BOTTLE (72887-143-06)
URSODIOL ursodiol CAPSULE;ORAL 205789 ANDA FH2 Pharma LLC 72887-144 72887-144-06 60 CAPSULE in 1 BOTTLE (72887-144-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:May 8, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:May 8, 2020TE:RLD:No

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