Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076168
Company: TEVA
Company: TEVA
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 |
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. |
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 |