You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 27, 2026

Details for New Drug Application (NDA): 021011


✉ Email this page to a colleague

« Back to Dashboard


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. Thirty-seven 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 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 23635-581 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: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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
© Copyright 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
 NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links