➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Harvard Business School
McKinsey
Mallinckrodt
Baxter

Last Updated: April 14, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203484

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 203484 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Granules Pharms, Mayne Pharma Inc, Cnty Line Pharms, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, and Watson Labs, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.

The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 203484
Tradename:BUTALBITAL AND ACETAMINOPHEN
Applicant:Larken Labs Inc
Ingredient:acetaminophen; butalbital
Patents:0
Pharmacology for NDA: 203484
Suppliers and Packaging for NDA: 203484
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLZITAL acetaminophen; butalbital TABLET;ORAL 203484 ANDA Larken Laboratories, Inc. 68047-721 68047-721-01 100 TABLET in 1 BOTTLE (68047-721-01)
ALLZITAL acetaminophen; butalbital TABLET;ORAL 203484 ANDA Larken Laboratories, Inc. 68047-721 68047-721-30 30 TABLET in 1 BOTTLE (68047-721-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;25MG
Approval Date:Dec 4, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG
Approval Date:Dec 4, 2015TE:AARLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Mallinckrodt
McKesson
Merck
Dow

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.

 
© Copyright 2002-2021 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2021 - 2022
 NCE-1 Patent Challenge Dates 2021 - 2022
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.

Links

Follow DrugPatentWatch:

  DrugPatentWatch Linkedin Group