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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Fish and Richardson
US Department of Justice

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089160

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NDA 089160 describes ANEXSIA, which is a drug marketed by Mallinckrodt and is included in five NDAs. It is available from seven suppliers. Additional details are available on the ANEXSIA profile page.

The generic ingredient in ANEXSIA 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 089160

Formulation / Manufacturing:see details

Pharmacology for NDA: 089160

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 089160

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANEXSIA acetaminophen; hydrocodone bitartrate TABLET;ORAL 089160 ANDA Liberty Pharmaceuticals, Inc. 0440-7610 0440-7610-10 10 TABLET in 1 BOTTLE, PLASTIC (0440-7610-10)
ANEXSIA acetaminophen; hydrocodone bitartrate TABLET;ORAL 089160 ANDA STAT RX USA LLC 16590-113 16590-113-86 270 TABLET in 1 BOTTLE (16590-113-86)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;5MG
Approval Date:Apr 23, 1987TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Cantor Fitzgerald

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