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Last Updated: December 14, 2024

Details for New Drug Application (NDA): 076758

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NDA 076758 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma, Sun Pharm Inds Inc, Endo Operations, Barr Labs Inc, and Watson Labs, and is included in fifty-one NDAs. It is available from thirty-seven suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for 076758

Tradename:	OXYCODONE HYDROCHLORIDE
Applicant:	Specgx Llc
Ingredient:	oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 076758

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 076758

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	076758	ANDA	SpecGx LLC	0406-0552	0406-0552-01	100 TABLET in 1 BOTTLE (0406-0552-01)
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	076758	ANDA	SpecGx LLC	0406-0552	0406-0552-23	1 TABLET in 1 BLISTER PACK (0406-0552-23)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 30, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jun 30, 2004	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 19, 2007	TE:	AB	RLD:	No

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