Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020932
Company: ROXANE

Products on NDA 020932

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROXICODONE	OXYCODONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ROXICODONE	OXYCODONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020932

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20932ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20932.cfm