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Generated: April 23, 2017

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Details for New Drug Application (NDA): 090801

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NDA 090801 describes URSODIOL, which is a drug marketed by Glenmark Generics, Epic Pharma, Impax Labs Inc, Mylan, Par Pharm, Lannett, Teva Pharms Usa, and Teva Pharms, and is included in nine NDAs. It is available from nineteen suppliers. Additional details are available on the URSODIOL profile page.

The generic ingredient in URSODIOL is ursodiol. There are five 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 NDA: 090801

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090801

Ingredient-typeBile Acids and Salts

Suppliers and Packaging for NDA: 090801

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090801 ANDA Glenmark Pharmaceuticals Inc., USA 68462-473 68462-473-01 100 TABLET in 1 BOTTLE (68462-473-01)
TABLET;ORAL 090801 ANDA Glenmark Pharmaceuticals Inc., USA 68462-473 68462-473-05 500 TABLET in 1 BOTTLE (68462-473-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 12, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 12, 2011TE:ABRLD:No

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