Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077923
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MELOXICAM | MELOXICAM | 7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| MELOXICAM | MELOXICAM | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077923s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/05/2023 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/08/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2016 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/21/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |