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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Chubb
Johnson and Johnson
Harvard Business School
Colorcon
Cipla
McKinsey
Merck

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078778

« Back to Dashboard

NDA 078778 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Macleods Pharms Ltd, Micro Labs Ltd India, Mylan, Par Pharm, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from thirty-five suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 078778
Tradename:TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Applicant:Apotex Inc
Ingredient:acetaminophen; tramadol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078778
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 078778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 078778 ANDA PD-Rx Pharmaceuticals, Inc. 43063-782 N 43063-782-20
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 078778 ANDA PD-Rx Pharmaceuticals, Inc. 43063-782 N 43063-782-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:Apr 7, 2014TE:ABRLD: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:

Johnson and Johnson
Cipla
UBS
AstraZeneca
Boehringer Ingelheim
Express Scripts
McKinsey
Daiichi Sankyo
Colorcon

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.