Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076168
Company: TEVA

Products on ANDA 076168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	80MG	TABLET, EXTENDED RELEASE; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2003	ORIG-1	Tentative Approval			Label (PDF) Letter (PDF) Patient Package Insert (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168pilbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076168_s000_OxycodoneTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2004	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 076168

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2003	ORIG-1	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf