BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Merck
Covington
McKinsey
Moodys
Argus Health
Healthtrust
Daiichi Sankyo
Johnson and Johnson
Julphar
Dow

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205120

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NDA 205120 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 205120
Tradename:BUTALBITAL AND ACETAMINOPHEN
Applicant:Cnty Line Pharms
Ingredient:acetaminophen; butalbital
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205120
Ingredient-typeBarbiturates
Suppliers and Packaging for NDA: 205120
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 205120 ANDA County Line Pharmaceuticals, LLC 43199-053 43199-053-01 100 TABLET in 1 BOTTLE (43199-053-01)
BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 205120 ANDA Alvogen, Inc. 47781-535 47781-535-01 100 TABLET in 1 BOTTLE (47781-535-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG
Approval Date:Oct 30, 2015TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Fish and Richardson
Harvard Business School
US Department of Justice
Julphar
Medtronic
Daiichi Sankyo
Johnson and Johnson

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