Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072262
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLOFENAMATE SODIUM | MECLOFENAMATE SODIUM | EQ 50MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/29/1988 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/10/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |