Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013400
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDOMET METHYLDOPA 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ALDOMET METHYLDOPA 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ALDOMET METHYLDOPA 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/20/1962 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2004 SUPPL-86 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13400s086ltr.pdf
11/10/1998 SUPPL-85 Labeling

Label is not available on this site.

08/05/1997 SUPPL-84 Labeling

Label is not available on this site.

07/07/1997 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1997 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1997 SUPPL-81 Labeling

Label is not available on this site.

11/30/1995 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

09/26/1994 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

12/16/1994 SUPPL-78 Labeling

Label is not available on this site.

09/03/1992 SUPPL-77 Labeling

Label is not available on this site.

09/13/1990 SUPPL-76 Labeling

Label is not available on this site.

11/22/1988 SUPPL-75 Labeling

Label is not available on this site.

04/26/1988 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

05/11/1987 SUPPL-73 Labeling

Label is not available on this site.

10/22/1985 SUPPL-72 Labeling

Label is not available on this site.

02/22/1985 SUPPL-71 Labeling

Label is not available on this site.

01/17/1985 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1984 SUPPL-69 Labeling

Label is not available on this site.

04/10/1984 SUPPL-68 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1984 SUPPL-67 Labeling

Label is not available on this site.

12/23/1983 SUPPL-66 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/01/1983 SUPPL-65 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1982 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/08/1982 SUPPL-63 Labeling

Label is not available on this site.

04/07/1982 SUPPL-62 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/11/1987 SUPPL-61 Labeling

Label is not available on this site.

10/14/1981 SUPPL-60 Labeling

Label is not available on this site.

08/28/1981 SUPPL-58 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/17/1981 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/17/1981 SUPPL-56 Labeling

Label is not available on this site.

08/28/1981 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1981 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1981 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1980 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1982 SUPPL-51 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/10/1979 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1979 SUPPL-48 Labeling

Label is not available on this site.

03/09/1979 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1978 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1978 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1978 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1977 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

07/25/1979 SUPPL-42 Labeling

Label is not available on this site.

06/08/1978 SUPPL-41 Labeling

Label is not available on this site.

08/24/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1977 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/06/1977 SUPPL-38 Labeling

Label is not available on this site.

02/15/1978 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/1977 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1977 SUPPL-35 Labeling

Label is not available on this site.

11/09/1976 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1976 SUPPL-33 Labeling

Label is not available on this site.

11/09/1976 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1976 SUPPL-31 Labeling

Label is not available on this site.

12/12/1975 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1976 SUPPL-29 Labeling

Label is not available on this site.

06/06/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/17/2004 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf

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