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Last Updated: March 30, 2023

Details for New Drug Application (NDA): 020675

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NDA 020675 describes URSO FORTE, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. Additional details are available on the URSO FORTE profile page.

The generic ingredient in URSO FORTE 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 020675
Tradename:URSO FORTE
Formulation / Manufacturing:see details
Pharmacology for NDA: 020675
Suppliers and Packaging for NDA: 020675
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
URSO 250 ursodiol TABLET;ORAL 020675 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2998 0591-2998-01 100 TABLET in 1 BOTTLE (0591-2998-01)
URSO 250 ursodiol TABLET;ORAL 020675 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3005 0591-3005-01 100 TABLET in 1 BOTTLE (0591-3005-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 10, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 21, 2004TE:ABRLD:Yes

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