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Harvard Business School
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089987

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NDA 089987 describes BUTAPAP, which is a drug marketed by Mikart and is included in two NDAs. It is available from three suppliers. Additional details are available on the BUTAPAP profile page.

The generic ingredient in BUTAPAP is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 089987
Ingredient:acetaminophen; butalbital
Formulation / Manufacturing:see details
Pharmacology for NDA: 089987
Suppliers and Packaging for NDA: 089987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTAPAP acetaminophen; butalbital TABLET;ORAL 089987 ANDA Par Pharmaceutical 0603-2540 N 0603-2540-21
BUTAPAP acetaminophen; butalbital TABLET;ORAL 089987 ANDA International Ethical Labs, Inc. 11584-0030 N 11584-0030-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG
Approval Date:Oct 26, 1992TE:AARLD:No

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