Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018389
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDOMET METHYLDOPA 250MG/5ML SUSPENSION;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
08/28/1981 ORIG-1 Approval Type 3 - New Dosage Form 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
08/05/1997 SUPPL-13 Labeling

Label is not available on this site.

08/05/1997 SUPPL-12 Labeling

Label is not available on this site.

12/16/1994 SUPPL-11 Labeling

Label is not available on this site.

09/03/1992 SUPPL-10 Labeling

Label is not available on this site.

09/13/1990 SUPPL-9 Labeling

Label is not available on this site.

11/22/1988 SUPPL-8 Labeling

Label is not available on this site.

05/11/1987 SUPPL-7 Labeling

Label is not available on this site.

10/22/1985 SUPPL-6 Labeling

Label is not available on this site.

02/22/1985 SUPPL-5 Labeling

Label is not available on this site.

03/05/1984 SUPPL-4 Labeling

Label is not available on this site.

12/23/1983 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/08/1982 SUPPL-2 Labeling

Label is not available on this site.

05/11/1987 SUPPL-1 Labeling

Label is not available on this site.

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