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Details for New Drug Application (NDA): 019594

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NDA 019594 describes ACTIGALL, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from nine suppliers. Additional details are available on the ACTIGALL profile page.

The generic ingredient in ACTIGALL 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: 019594

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019594

Ingredient-typeBile Acids and Salts

Suppliers and Packaging for NDA: 019594

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 019594 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3159 0591-3159-01 100 CAPSULE in 1 BOTTLE (0591-3159-01)
CAPSULE;ORAL 019594 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1374 0615-1374-39 30 CAPSULE in 1 BLISTER PACK (0615-1374-39)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength150MG
Approval Date:Dec 31, 1987TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 31, 1987TE:ABRLD:Yes

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