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Generated: November 20, 2018

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Details for New Drug Application (NDA): 021011

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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. Fifty-six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021011
Mechanism of ActionFull 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 23635-580 23635-580-10 100 TABLET in 1 BOTTLE, PLASTIC (23635-580-10)
ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011 NDA SpecGx LLC 23635-580 23635-580-25 4 BLISTER PACK in 1 CARTON (23635-580-25) > 25 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Aug 31, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Aug 31, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 15, 2009TE:ABRLD:Yes

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