Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Argus Health
Covington
AstraZeneca
Johnson and Johnson
Fish and Richardson
Colorcon
Harvard Business School
UBS

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089828

« Back to Dashboard

NDA 089828 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Actavis Mid Atlantic, Allied Pharma Inc, Dava Pharms Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Vintage Pharms, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Anda Repository, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from fifty-two suppliers. Additional details are available on the ACETAMINOPHEN AND CODEINE PHOSPHATE profile page.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 089828
Tradename:ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:Vintage Pharms
Ingredient:acetaminophen; codeine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089828
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 089828
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089828 ANDA Liberty Pharmaceuticals, Inc. 0440-7027 N 0440-7027-30
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089828 ANDA Liberty Pharmaceuticals, Inc. 0440-7027 N 0440-7027-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;60MG
Approval Date:Sep 30, 1988TE:AARLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Department of Justice
Moodys
Citi
McKesson
Boehringer Ingelheim
QuintilesIMS
Colorcon
UBS

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.