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Last Updated: April 9, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207709


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NDA 207709 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Mikart, Anda Repository, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Vintage Pharms, Vistapharm, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen Pine Brook, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Epic Pharma Llc, Granules Pharms, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Nostrum Labs Inc, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Tris Pharma Inc, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, and Xiromed, and is included in one hundred and twenty-four NDAs. It is available from fifty-two 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. Fifty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 207709
Pharmacology for NDA: 207709
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 207709
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 207709 ANDA Aurolife Pharma, LLC 13107-211 13107-211-01 100 TABLET in 1 BOTTLE (13107-211-01)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 207709 ANDA Aurolife Pharma, LLC 13107-211 13107-211-05 500 TABLET in 1 BOTTLE (13107-211-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;5MG
Approval Date:Sep 13, 2018TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;7.5MG
Approval Date:Sep 13, 2018TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;10MG
Approval Date:Sep 13, 2018TE:AARLD:No

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