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Details for New Drug Application (NDA): 020675

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

The generic ingredient in URSO FORTE is ursodiol. There are five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

Summary for NDA: 020675

Tradename:
URSO 250
Applicant:
Forest Labs Inc
Ingredient:
ursodiol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020675

Ingredient-typeBile Acids and Salts

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 10, 1997TE:ABRLD:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020675

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Inc
URSO 250
ursodiol
TABLET;ORAL020675-001Dec 10, 19974,859,660► subscribe
Forest Labs Inc
URSO FORTE
ursodiol
TABLET;ORAL020675-002Jul 21, 20044,859,660► subscribe
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