Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018006
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.

06/07/1988 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1987 SUPPL-14 Labeling

Label is not available on this site.

07/23/1990 SUPPL-13 Efficacy-New Indication

Label is not available on this site.

11/20/1985 SUPPL-12 Labeling

Label is not available on this site.

07/23/1990 SUPPL-11 Efficacy-New Indication

Label is not available on this site.

05/15/1985 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/30/1988 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

04/09/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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.

04/11/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1980 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

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