Details for New Drug Application (NDA): 021011

NDA 021011 describes ROXICODONE, which is a drug marketed by Roxane and Specgx Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the ROXICODONE profile page.

The generic ingredient in ROXICODONE is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for 021011

Tradename:	ROXICODONE
Applicant:	Specgx Llc
Ingredient:	oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 021011

Mechanism of Action

Full Opioid Agonists

Suppliers and Packaging for NDA: 021011

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROXICODONE	oxycodone hydrochloride	TABLET;ORAL	021011	NDA	SpecGx LLC	23635-581	23635-581-10	100 TABLET in 1 BOTTLE, PLASTIC (23635-581-10)
ROXICODONE	oxycodone hydrochloride	TABLET;ORAL	021011	NDA	SpecGx LLC	23635-582	23635-582-10	100 TABLET in 1 BOTTLE, PLASTIC (23635-582-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Aug 31, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Aug 31, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 15, 2009	TE:	AB	RLD:	Yes

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