Last Updated: September 28, 2026

Details for New Drug Application (NDA): 219647

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NDA 219647 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms, Mylan, Ph Health, Strides Pharma Intl, Sun Pharm, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Puracap Labs Blu, Rubicon Research, Senores Pharms, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Rising, and Zydus Pharms Usa Inc, and is included in forty-six NDAs. It is available from thirty-nine suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 219647

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Novitium Pharma
Ingredient:	tramadol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 219647

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/ML
Approval Date:	Jun 26, 2026	TE:		RLD:	No

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