Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071469
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLOFENAMATE SODIUM | MECLOFENAMATE SODIUM | EQ 100MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 04/15/1987 | 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-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/25/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 04/29/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/25/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/17/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/14/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 08/29/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/12/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |