Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075189
Company: IMPAX LABS INC
Company: IMPAX LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
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 |
---|---|---|---|---|---|---|---|
05/26/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75189AP-TA.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75189ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/09/2016 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/10/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
05/19/2006 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
03/17/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/02/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
05/21/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
06/21/2002 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
09/24/2001 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf |
09/24/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/26/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf |