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Generated: November 23, 2017

DrugPatentWatch Database Preview

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

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

Summary for 019594

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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
ACTIGALL
ursodiol
CAPSULE;ORAL 019594 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3159 0591-3159-01 100 CAPSULE in 1 BOTTLE (0591-3159-01)
ACTIGALL
ursodiol
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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Serving leading biopharmaceutical companies globally:

Cipla
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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