➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

Last Updated: October 18, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019574

Email this page to a colleague

« Back to Dashboard

NDA 019574 describes THALITONE, which is a drug marketed by Casper Pharma Llc and Monarch Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the THALITONE profile page.

The generic ingredient in THALITONE is chlorthalidone. There are twenty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.
Summary for 019574
Applicant:Casper Pharma Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 019574
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 019574
Suppliers and Packaging for NDA: 019574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THALITONE chlorthalidone TABLET;ORAL 019574 NDA Casper Pharma LLC 70199-001 70199-001-01 100 TABLET in 1 BOTTLE (70199-001-01)
THALITONE chlorthalidone TABLET;ORAL 019574 NDA Casper Pharma LLC 70199-001 70199-001-30 30 TABLET in 1 BOTTLE (70199-001-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 12, 1992TE:BXRLD:Yes

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Harvard Business School

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.