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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207152


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NDA 207152 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, Mpp Pharma, Rising, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 207152
Tradename:TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Applicant:Aurobindo Pharma
Ingredient:acetaminophen; tramadol hydrochloride
Patents:0
Pharmacology for NDA: 207152
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 207152
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 207152 ANDA Medsource Pharmaceuticals 45865-170 45865-170-60 60 TABLET, FILM COATED in 1 BOTTLE (45865-170-60)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 207152 ANDA St. Mary's Medical Park Pharmacy 60760-922 60760-922-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-922-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:Mar 22, 2017TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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