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Last Updated: October 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206885

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NDA 206885 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Mylan, Nostrum Labs Inc, Par Pharm, Rising, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from twenty-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. Twenty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 206885
Pharmacology for NDA: 206885
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 206885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 206885 ANDA Macleods Pharmaceuticals Limited 33342-202 33342-202-11 100 TABLET in 1 BOTTLE (33342-202-11)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 206885 ANDA Macleods Pharmaceuticals Limited 33342-202 33342-202-12 10 BLISTER PACK in 1 CARTON (33342-202-12) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:May 2, 2017TE:RLD:No

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