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Details for Generic Name: oxycodone hydrochloride

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Oxycodone hydrochloride is the generic ingredient in four branded drugs marketed by Coastal Pharms, Lannett Holdings Inc, Lehigh Valley, Roxane, Vistapharm, Purdue Pharma Lp, Acura Pharms Inc, Actavis Elizabeth, Alvogen Inc, Amneal Pharms, Aurolife Pharma Llc, Avanthi Inc, Corepharma, Mallinckrodt Inc, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, and Vintage Pharms, and is included in twenty-six NDAs. There are fourteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for oxycodone hydrochloride. Sixteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: oxycodone hydrochloride

Drug Master File Entries: see list17
Suppliers: see list16
Therapeutic Class:Analgesics

Pharmacology for Ingredient: oxycodone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL20MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL40MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL80MG

Clinical Trials for: oxycodone hydrochloride

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
Status: Completed Condition: Management of Moderate to Severe Pain

Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
Status: Recruiting Condition: Arthroplasty, Replacement, Hip

Pharmacokinetics Study of ALO-02 and OxyContin
Status: Completed Condition: Management of Moderate to Severe Pain

Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
Status: Completed Condition: Effects of 2 Mu-opiates on Gastrointestinal Transit

Abuse Liability of Controlled-Release Oxycodone Formulations
Status: Recruiting Condition: Substance-Related Disorders

Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Status: Completed Condition: Pain

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272Apr 5, 2010RXNo7,683,072<disabled>Y<disabled>
Vintage Pharms
oxycodone hydrochloride
TABLET;ORAL077712Mar 2, 2009RXNo<disabled><disabled>
Purdue Pharma Lp
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272Apr 5, 2010RXYes7,683,072<disabled>Y<disabled>
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL020932Oct 26, 1998DISCNNo<disabled><disabled>
Rhodes Pharms
oxycodone hydrochloride
TABLET;ORAL091490Mar 9, 2011RXNo<disabled><disabled>
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