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Serving leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Harvard Business School
Healthtrust
Mallinckrodt
Merck
Julphar
Baxter
Cipla
US Army

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040356

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NDA 040356 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Par Pharm, Barr, Mikart, Mallinckrodt Inc, Ucb Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Tris Pharma Inc, Vintage Pharms, Sun Pharm Inds Inc, Ranbaxy Labs Ltd, Watson Labs, Ranbaxy, Sun Pharm Inds Ltd, Pharm Assoc, Larken Labs Inc, Abhai Llc, Mutual Pharm, Amneal Pharms, Novel Labs Inc, Vistapharm, Apil, Sandoz, Halsey, Able, Caraco, Nesher Pharms, Actavis Labs Fl Inc, Lannett Holdings Inc, Vintage Pharms Llc, Upsher-smith Labs, Usl Pharma, Rhodes Pharms, Watson Labs Florida, and Ivax Pharms, and is included in one hundred and twelve NDAs. It is available from eighty-three 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. Eighty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 040356

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040356

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040356 ANDA Rebel Distributors Corp 42254-079 42254-079-08 8 TABLET in 1 BOTTLE, PLASTIC (42254-079-08)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040356 ANDA Rebel Distributors Corp 42254-079 42254-079-10 10 TABLET in 1 BOTTLE, PLASTIC (42254-079-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;10MG
Approval Date:May 31, 2000TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Fish and Richardson
Express Scripts
Daiichi Sankyo
Medtronic
QuintilesIMS
Colorcon
US Department of Justice
Boehringer Ingelheim

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