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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
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Generated: July 25, 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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 040405

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:

Johnson and Johnson
US Department of Justice
Express Scripts
Cantor Fitzgerald

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