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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210707


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NDA 210707 describes URSODIOL, which is a drug marketed by Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Eywa Pharma, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Mylan, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus, Glenmark Generics, Par Pharm, and Teva Pharms Usa, and is included in twenty-one NDAs. It is available from twenty-six 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-eight suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 210707
Tradename:URSODIOL
Applicant:Abhai Llc
Ingredient:ursodiol
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 210707
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol CAPSULE;ORAL 210707 ANDA PD-Rx Pharmaceuticals, Inc. 43063-871 43063-871-01 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)
URSODIOL ursodiol CAPSULE;ORAL 210707 ANDA PD-Rx Pharmaceuticals, Inc. 43063-871 43063-871-60 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:May 17, 2018TE:ABRLD:No

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