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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission

Generated: December 10, 2017

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 five 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. Sixteen suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for 089987

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 Qualitest Pharmaceuticals 0603-2540 0603-2540-21 100 TABLET in 1 BOTTLE (0603-2540-21)
BUTAPAP acetaminophen; butalbital TABLET;ORAL 089987 ANDA Marnel Pharmaceuticals, Inc. 0682-1400 0682-1400-01 100 TABLET in 1 BOTTLE, PLASTIC (0682-1400-01)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Chinese Patent Office
Daiichi Sankyo

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