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Serving 500+ biopharmaceutical companies globally:

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Generated: July 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040881

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NDA 040881 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: 040881

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040881

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040881

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
SOLUTION;ORAL 040881 ANDA Akorn, Inc. 17478-450 17478-450-16 473 mL in 1 BOTTLE, PLASTIC (17478-450-16)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
SOLUTION;ORAL 040881 ANDA Atlantic Biologicals Corps 17856-0450 17856-0450-1 15 mL in 1 CUP, UNIT-DOSE (17856-0450-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength300MG/15ML;10MG/15ML
Approval Date:Feb 25, 2010TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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