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Generated: June 26, 2017

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, Tedor Pharma Inc, Watson Labs, Nexgen Pharma, Halsey, Larken Labs Inc, and Mikart Inc, and is included in seven NDAs. It is available from thirteen 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-five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for NDA: 203484

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
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 e5 Pharma, LLC 13517-109 13517-109-10 100 TABLET in 1 BOTTLE (13517-109-10)
ALLZITAL
acetaminophen; butalbital
 TABLET;ORAL 203484 ANDA STI Pharma LLC 54879-026 54879-026-01 100 TABLET in 1 BOTTLE (54879-026-01)

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Colorcon
Teva
Mallinckrodt
AstraZeneca
Merck
Chinese Patent Office
Baxter
Boehringer Ingelheim
Novartis
UBS

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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