Last Updated: June 9, 2026

Details for New Drug Application (NDA): 211145


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NDA 211145 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, Quagen, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Epic Pharma Llc, Glenmark Pharms Ltd, Ph Health, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from twenty-seven 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 211145
Tradename:URSODIOL
Applicant:Zydus Lifesciences
Ingredient:ursodiol
Patents:0
Pharmacology for NDA: 211145
Suppliers and Packaging for NDA: 211145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol TABLET;ORAL 211145 ANDA American Health Packaging 60687-527 60687-527-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11)
URSODIOL ursodiol TABLET;ORAL 211145 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1127 70710-1127-1 100 TABLET in 1 BOTTLE (70710-1127-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 30, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 30, 2018TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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