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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040094

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NDA 040094 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-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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 040094

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

Pharmacology for NDA: 040094

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040094

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040094 ANDA STAT Rx USA LLC 16590-116 16590-116-20 20 TABLET in 1 BOTTLE (16590-116-20)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 040094 ANDA STAT Rx USA LLC 16590-116 16590-116-30 30 TABLET in 1 BOTTLE (16590-116-30)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;7.5MG
Approval Date:Sep 29, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;10MG
Approval Date:Sep 29, 1995TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength660MG;10MG
Approval Date:Aug 8, 2000TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
Farmers Insurance
Dow
Covington
Julphar
Medtronic
Harvard Business School
Daiichi Sankyo
Teva
Fish and Richardson

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