Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077936
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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/2006/077936s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/17/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/17/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/17/2016 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/02/2010 | SUPPL-11 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/07/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/28/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/11/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/19/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/07/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |