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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 040834


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NDA 040834 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Cerovene Inc, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, and Watson Labs Florida, and is included in one hundred and twenty-six NDAs. It is available from forty-one suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND ACETAMINOPHEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040834
Pharmacology for NDA: 040834
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 040834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 040834 ANDA Genus Lifesciences Inc. 64950-375 64950-375-16 473 mL in 1 BOTTLE (64950-375-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength325MG/15ML;10MG/15ML
Approval Date:Apr 18, 2008TE:RLD:No

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