Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074410
Company: CHARTWELL MOLECULES
Company: CHARTWELL MOLECULES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Discontinued | None | No | No |
| NAPROXEN | NAPROXEN | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/28/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/09/2017 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/17/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/31/2006 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/19/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/19/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/19/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/27/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |