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Details for New Drug Application (NDA): 040468

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NDA 040468 describes ANEXSIA, which is a drug marketed by Mallinckrodt and is included in five NDAs. It is available from eleven suppliers. Additional details are available on the ANEXSIA profile page.

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

Summary for NDA: 040468

acetaminophen; hydrocodone bitartrate

Pharmacology for NDA: 040468

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040468

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040468 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-052 49999-052-01 120 TABLET in 1 BOTTLE, PLASTIC (49999-052-01)
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040468 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-052 49999-052-00 100 TABLET in 1 BOTTLE, PLASTIC (49999-052-00)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG;10MG
Approval Date:Oct 31, 2002TE:RLD:No

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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.