BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Healthtrust
Chinese Patent Office
Boehringer Ingelheim
Baxter
Fuji
Novartis
Cerilliant
QuintilesIMS
Farmers Insurance
Accenture

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040826

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NDA 040826 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-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. Eighty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040826
Tradename:HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Applicant:Sun Pharm Inds Ltd
Ingredient:acetaminophen; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040826
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 040826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040826 ANDA Ranbaxy Pharmaceuticals Inc. 63304-497 63304-497-03 10 TABLET in 1 BOTTLE (63304-497-03)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040826 ANDA Ranbaxy Pharmaceuticals Inc. 63304-497 63304-497-10 1000 TABLET in 1 BOTTLE (63304-497-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Aug 16, 2007TE:RLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Dow
Farmers Insurance
Healthtrust
McKinsey
Cantor Fitzgerald
Fuji
Cipla
Daiichi Sankyo

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