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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 075968

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NDA 075968 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 075968

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Graviti Pharms
Ingredient:	tramadol hydrochloride
Patents:	0

Pharmacology for NDA: 075968

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 075968

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 075968

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075968	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-727	60760-727-20	20 TABLET in 1 BOTTLE, PLASTIC (60760-727-20)
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075968	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-727	60760-727-30	30 TABLET in 1 BOTTLE, PLASTIC (60760-727-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 25, 2002	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Aug 2, 2024	TE:	AB	RLD:	No

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