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Serving leading biopharmaceutical companies globally:

Chinese Patent Office

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077727

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NDA 077727 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 twenty-one 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-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
Summary for 077727
Applicant:Vintage Pharms
Ingredient:hydrocodone bitartrate; ibuprofen
Formulation / Manufacturing:see details
Pharmacology for NDA: 077727
Suppliers and Packaging for NDA: 077727
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077727 ANDA Par Pharmaceutical 0603-3584 0603-3584-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3584-21)
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077727 ANDA Poly Pharmaceuticals 50991-578 50991-578-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-578-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;200MG
Approval Date:Nov 6, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
US Department of Justice
Harvard Business School
Farmers Insurance

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