You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Harvard Business School

Last Updated: February 26, 2024

Details for New Drug Application (NDA): 019594

✉ Email this page to a colleague

« Back to Dashboard

NDA 019594 describes ACTIGALL, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two 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-eight suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 019594
Applicant:Teva Branded Pharm
Formulation / Manufacturing:see details
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 AUTHORIZED GENERIC AvKARE 42291-923 42291-923-01 100 CAPSULE in 1 BOTTLE (42291-923-01)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts

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 verification 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.