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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cerilliant
AstraZeneca
QuintilesIMS
Colorcon
Chubb
McKinsey
Covington
Express Scripts
Boehringer Ingelheim

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040288

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NDA 040288 describes ZYDONE, which is a drug marketed by Vintage Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ZYDONE profile page.

The generic ingredient in ZYDONE is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Eighty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for 040288

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040288

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040288

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYDONE acetaminophen; hydrocodone bitartrate TABLET;ORAL 040288 ANDA STAT RX USA LLC 16590-350 16590-350-62 84 TABLET in 1 BOTTLE (16590-350-62)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG;5MG
Approval Date:Nov 27, 1998TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG;7.5MG
Approval Date:Nov 27, 1998TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG;10MG
Approval Date:Nov 27, 1998TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
Argus Health
Johnson and Johnson
Baxter
Teva
QuintilesIMS
Federal Trade Commission
Harvard Business School
Merck
Daiichi Sankyo

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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