Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071081
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLOFENAMATE SODIUM | MECLOFENAMATE SODIUM | EQ 100MG BASE | CAPSULE;ORAL | Prescription | None | No | Yes |
| MECLOFENAMATE SODIUM | MECLOFENAMATE SODIUM | EQ 50MG BASE | CAPSULE;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 09/03/1986 | 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-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/04/2015 | SUPPL-18 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/09/2002 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/05/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/28/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/05/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/08/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/09/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |