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Colorcon
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Cipla
Teva
Covington
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077184

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NDA 077184 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Amneal Pharms, Apogee Pharma, 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 077184
Tradename:TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Applicant:Sun Pharm Inds Inc
Ingredient:acetaminophen; tramadol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077184
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 077184
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 077184 ANDA STAT Rx USA LLC 42549-569 42549-569-60 60 TABLET, FILM COATED in 1 BOTTLE (42549-569-60)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 077184 ANDA STAT Rx USA LLC 42549-569 42549-569-90 90 TABLET, FILM COATED in 1 BOTTLE (42549-569-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:Dec 16, 2005TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
Queensland Health
US Army
Deloitte
Julphar
Fish and Richardson
Argus Health
Merck
McKinsey

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