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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Federal Trade Commission

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077723

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NDA 077723 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, and Vintage Pharms, and is included in eight NDAs. It is available from fifteen suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND IBUPROFEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND IBUPROFEN is hydrocodone bitartrate; ibuprofen. There are twenty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
Summary for 077723
Applicant:Vintage Pharms
Ingredient:hydrocodone bitartrate; ibuprofen
Formulation / Manufacturing:see details
Pharmacology for NDA: 077723
Suppliers and Packaging for NDA: 077723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077723 ANDA Par Pharmaceutical 0603-3586 N 0603-3586-21
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077723 ANDA Par Pharmaceutical 0603-3897 N 0603-3897-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:Nov 6, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;200MG
Approval Date:Nov 6, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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US Army
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