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Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
US Department of Justice

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088058

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NDA 088058 describes VICODIN, which is a drug marketed by Abbott and Abbvie and is included in four NDAs. It is available from one supplier. Additional details are available on the VICODIN profile page.

The generic ingredient in VICODIN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 088058
Ingredient:acetaminophen; hydrocodone bitartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 088058
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 088058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VICODIN acetaminophen; hydrocodone bitartrate TABLET;ORAL 088058 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-051 E 49999-051-90
VICODIN acetaminophen; hydrocodone bitartrate TABLET;ORAL 088058 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-051 E 49999-051-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;5MG
Approval Date:Jan 7, 1983TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Express Scripts

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