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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 079082


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NDA 079082 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 079082
Tradename:URSODIOL
Applicant:Lannett Co Inc
Ingredient:ursodiol
Patents:0
Pharmacology for NDA: 079082
Suppliers and Packaging for NDA: 079082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSODIOL ursodiol CAPSULE;ORAL 079082 ANDA Lannett Company, Inc. 0527-1326 0527-1326-01 100 CAPSULE in 1 BOTTLE (0527-1326-01)
URSODIOL ursodiol CAPSULE;ORAL 079082 ANDA American Health Packaging 60687-100 60687-100-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-100-01) / 1 CAPSULE in 1 BLISTER PACK (60687-100-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 15, 2008TE:ABRLD:No

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