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Generated: April 18, 2019

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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 five suppliers. Additional details are available on the ACTIGALL profile page.

The generic ingredient in ACTIGALL is ursodiol. There are eight 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 019594
Applicant:Allergan Sales Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 019594
Suppliers and Packaging for NDA: 019594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTIGALL ursodiol CAPSULE;ORAL 019594 NDA Allergan, Inc. 0023-6145 0023-6145-01 100 CAPSULE in 1 BOTTLE (0023-6145-01)
ACTIGALL ursodiol CAPSULE;ORAL 019594 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3159 0591-3159-01 100 CAPSULE in 1 BOTTLE (0591-3159-01)

Profile for product number 001

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

Profile for product number 002

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

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