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Details for New Drug Application (NDA): 088058

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NDA 088058 describes VICODIN, which is a drug marketed by Abbvie and Abbott 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-five drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 088058

Tradename:
VICODIN
Applicant:
Abbvie
Ingredient:
acetaminophen; hydrocodone bitartrate
Patents:0
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 49999-051-30 30 TABLET in 1 BOTTLE (49999-051-30)
VICODIN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 088058 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-051 49999-051-60 60 TABLET in 1 BOTTLE (49999-051-60)

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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