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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040084

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NDA 040084 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, 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 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 040084
Tradename:HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Applicant:Mallinckrodt
Ingredient:acetaminophen; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040084
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 040084
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040084 ANDA Rebel Distributors Corp 42254-223 E 42254-223-30
HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040084 ANDA Rebel Distributors Corp 42254-223 E 42254-223-20

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG;7.5MG
Approval Date:Jun 1, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;5MG
Approval Date:Jun 1, 1995TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength660MG;10MG
Approval Date:Jul 29, 1996TE:RLD:No

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