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Serving 500+ biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Colorcon
Citi
McKinsey
Federal Trade Commission
Johnson and Johnson
Mallinckrodt
Farmers Insurance
Accenture

Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040405

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NDA 040405 describes ANEXSIA 7.5/325, which is a drug marketed by Mallinckrodt and is included in one NDA. It is available from six suppliers. Additional details are available on the ANEXSIA 7.5/325 profile page.

The generic ingredient in ANEXSIA 7.5/325 is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 040405

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

Pharmacology for NDA: 040405

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040405

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANEXSIA 7.5/325
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040405 ANDA Mallinckrodt, Inc. 0406-0124 0406-0124-01 100 TABLET in 1 BOTTLE (0406-0124-01)
ANEXSIA 7.5/325
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040405 ANDA Mallinckrodt, Inc. 0406-0124 0406-0124-05 500 TABLET in 1 BOTTLE (0406-0124-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Sep 8, 2000TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Chinese Patent Office
UBS
Baxter
Novartis
Citi
Dow
Healthtrust
Cerilliant

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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