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Generated: May 28, 2017

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

Summary for NDA: 205120

Formulation / Manufacturing:see details

Pharmacology for NDA: 205120


Suppliers and Packaging for NDA: 205120

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; butalbital
TABLET;ORAL 205120 ANDA County Line Pharmaceuticals, LLC 43199-053 43199-053-01 100 TABLET in 1 BOTTLE (43199-053-01)
acetaminophen; butalbital
TABLET;ORAL 205120 ANDA Alvogen, Inc. 47781-535 47781-535-01 100 TABLET in 1 BOTTLE (47781-535-01)

Summary for product number 001

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

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