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Serving leading biopharmaceutical companies globally:

Cipla
Novartis
Cantor Fitzgerald
Harvard Business School
Citi
Deloitte
Julphar
Baxter
Fish and Richardson
McKinsey

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203484

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NDA 203484 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Cnty Line Pharms, Halsey, Larken Labs Inc, Mikart Inc, Nexgen Pharma, Tedor Pharma Inc, and Watson Labs, and is included in seven NDAs. It is available from eleven 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. Fourteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 203484
Ingredient-typeBarbiturates
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 STI Pharma LLC 54879-026 54879-026-01 100 TABLET in 1 BOTTLE (54879-026-01)
ALLZITAL acetaminophen; butalbital TABLET;ORAL 203484 ANDA Larken Laboratories, Inc. 68047-721 68047-721-01 100 TABLET in 1 BOTTLE (68047-721-01)

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

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Serving leading biopharmaceutical companies globally:

Teva
QuintilesIMS
Daiichi Sankyo
Covington
Federal Trade Commission
Chubb
Dow
Cerilliant
US Army

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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