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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Cipla
Chinese Patent Office
Mallinckrodt
Johnson and Johnson
Express Scripts
Medtronic
US Army
Argus Health

Generated: December 11, 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, 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, Halsey, Ivax Pharms, Lannett Holdings Inc, Larken Labs Inc, Mutual Pharm, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, 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 thirteen NDAs. It is available from eighty 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-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for 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 42254-079-60 60 TABLET in 1 BOTTLE, PLASTIC (42254-079-60)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040356 ANDA Rebel Distributors Corp 42254-079 42254-079-90 90 TABLET in 1 BOTTLE, PLASTIC (42254-079-90)

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:

US Army
US Department of Justice
Julphar
Chinese Patent Office
McKinsey
AstraZeneca
Healthtrust
Fuji
Cerilliant
Baxter

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