Generated: September 20, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 081051
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-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. Eighty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for NDA: 081051
|Formulation / Manufacturing:||see details|Complete Access Available with Subscription
Summary for product number 001
|Approval Date:||Aug 28, 1992||TE:||RLD:||No|
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