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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 200503

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NDA 200503 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, 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, Mpp Pharma, Rising, and Zydus Pharms Usa Inc, and is included in forty-five NDAs. It is available from forty-one suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE 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 200503

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Lupin Ltd
Ingredient:	tramadol hydrochloride
Patents:	0

Pharmacology for NDA: 200503

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 200503

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 200503

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200503	ANDA	Medsource Pharmaceuticals	45865-184	45865-184-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30)
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200503	ANDA	A-S Medication Solutions	50090-5107	50090-5107-0	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5107-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Aug 29, 2011	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Aug 29, 2011	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Aug 29, 2011	TE:	AB1	RLD:	No

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