Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040199
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;5MG | CAPSULE;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
12/30/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40199_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40199_Oxycodone%20and%20Acetaminophen_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040199_oxycodone_toc.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40199_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf |