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Generated: October 21, 2018

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Details for New Drug Application (NDA): 089160

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NDA 089160 describes ANEXSIA, which is a drug marketed by Mallinckrodt and Specgx Llc and is included in five NDAs. It is available from four 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. Seventy-five suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 089160
Ingredient:acetaminophen; hydrocodone bitartrate
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 Medsource Pharmaceuticals 45865-407 45865-407-06 6 TABLET in 1 BOTTLE (45865-407-06)

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Queensland Health

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