Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018006
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLOMEN | MECLOFENAMATE SODIUM | EQ 50MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| MECLOMEN | MECLOFENAMATE SODIUM | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1980 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 06/07/1988 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/10/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/23/1990 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
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| 11/20/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/23/1990 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
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| 05/15/1985 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/30/1988 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
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| 04/09/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/11/1981 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/06/1980 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |