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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 201194

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NDA 201194 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-eight 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 201194

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

Pharmacology for NDA: 201194

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 201194

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	201194	NDA	VistaPharm, LLC	66689-401	66689-401-50	5 TRAY in 1 CASE (66689-401-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-401-01)
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	201194	NDA	VistaPharm, LLC	66689-403	66689-403-16	500 mL in 1 BOTTLE (66689-403-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Jan 12, 2012	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 21, 2024
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

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