Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075179
Company: COPLEY PHARM
Company: COPLEY PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NABUMETONE | NABUMETONE | 750MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/06/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-179_Nabumetone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75179TAAP.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-179_Nabumetone.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/06/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-179_Nabumetone_prntlbl.pdf |