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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201952


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NDA 201952 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 201952
Tradename:TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Applicant:Micro Labs Ltd India
Ingredient:acetaminophen; tramadol hydrochloride
Patents:0
Pharmacology for NDA: 201952
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 201952
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 201952 ANDA Micro Labs Limited 42571-119 42571-119-01 100 TABLET, FILM COATED in 1 BOTTLE (42571-119-01)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 201952 ANDA Micro Labs Limited 42571-119 42571-119-05 500 TABLET, FILM COATED in 1 BOTTLE (42571-119-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:Dec 14, 2012TE:ABRLD:No

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Preferred Citation:

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