Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016016
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDOCLOR-150 CHLOROTHIAZIDE; METHYLDOPA 150MG;250MG TABLET;ORAL Discontinued None No No
ALDOCLOR-250 CHLOROTHIAZIDE; METHYLDOPA 250MG;250MG TABLET;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
03/20/1968 ORIG-1 Approval Type 4 - New Combination 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
08/22/1999 SUPPL-70 Labeling

Label is not available on this site.

08/05/1997 SUPPL-69 Labeling

Label is not available on this site.

05/23/1997 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1994 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

12/16/1994 SUPPL-66 Labeling

Label is not available on this site.

06/30/1994 SUPPL-65 Labeling

Label is not available on this site.

09/17/1992 SUPPL-64 Labeling

Label is not available on this site.

09/13/1990 SUPPL-63 Labeling

Label is not available on this site.

09/06/1988 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-61 Labeling

Label is not available on this site.

04/21/1988 SUPPL-60 Labeling

Label is not available on this site.

08/26/1987 SUPPL-59 Labeling

Label is not available on this site.

08/15/1988 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1986 SUPPL-57 Labeling

Label is not available on this site.

01/14/1986 SUPPL-56 Labeling

Label is not available on this site.

09/24/1984 SUPPL-55 Labeling

Label is not available on this site.

04/03/1984 SUPPL-54 Labeling

Label is not available on this site.

12/23/1983 SUPPL-53 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/21/1982 SUPPL-52 Labeling

Label is not available on this site.

05/08/1987 SUPPL-51 Labeling

Label is not available on this site.

09/23/1981 SUPPL-50 Labeling

Label is not available on this site.

06/17/1981 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1981 SUPPL-48 Labeling

Label is not available on this site.

04/09/1981 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1981 SUPPL-46 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/13/1981 SUPPL-45 Labeling

Label is not available on this site.

11/14/1980 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1981 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/29/1979 SUPPL-42 Labeling

Label is not available on this site.

07/03/1979 SUPPL-41 Labeling

Label is not available on this site.

09/18/1979 SUPPL-40 Labeling

Label is not available on this site.

03/09/1979 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1978 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1978 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1979 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/18/1979 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1978 SUPPL-34 Labeling

Label is not available on this site.

02/15/1978 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/1978 SUPPL-32 Labeling

Label is not available on this site.

11/09/1976 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1976 SUPPL-30 Labeling

Label is not available on this site.

06/06/1975 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

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