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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Citi
Teva
Farmers Insurance
QuintilesIMS
Argus Health
Colorcon
Express Scripts
Daiichi Sankyo

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040769

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NDA 040769 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Mikart, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Vintage Pharms, Vistapharm, Abhai Llc, Able, Actavis Labs Fl Inc, Amneal Pharms, Amneal Pharms Ny, Apil, Aurolife Pharma Llc, Barr, Caraco, Epic Pharma Llc, Halsey, Ivax Pharms, Lannett Holdings Inc, Larken Labs Inc, Mutual Pharm, 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 Wes Pharma Inc, and is included in one hundred and fifteen NDAs. It is available from seventy-seven 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. Seventy-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040769
Tradename:HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Applicant:Amneal Pharms Ny
Ingredient:acetaminophen; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040769
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 040769
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040769 ANDA RedPharm Drug Inc. 67296-0377 N 67296-0377-1
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040769 ANDA RedPharm Drug Inc. 67296-0377 N 67296-0377-2

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG;7.5MG
Approval Date:Aug 28, 2006TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Chubb
Boehringer Ingelheim
Johnson and Johnson
US Army
Argus Health
Express Scripts
Mallinckrodt
Medtronic

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