Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013402
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDORIL 15 HYDROCHLOROTHIAZIDE; METHYLDOPA 15MG;250MG TABLET;ORAL Discontinued None No No
ALDORIL 25 HYDROCHLOROTHIAZIDE; METHYLDOPA 25MG;250MG TABLET;ORAL Discontinued None No No
ALDORIL D30 HYDROCHLOROTHIAZIDE; METHYLDOPA 30MG;500MG TABLET;ORAL Discontinued None No No
ALDORIL D50 HYDROCHLOROTHIAZIDE; METHYLDOPA 50MG;500MG 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
12/20/1962 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
12/14/2004 SUPPL-85 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13402s085ltr.pdf
04/05/2002 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

07/02/1998 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1999 SUPPL-81 Labeling

Label is not available on this site.

08/05/1997 SUPPL-80 Labeling

Label is not available on this site.

11/29/1995 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

09/26/1994 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

12/16/1994 SUPPL-77 Labeling

Label is not available on this site.

03/07/1994 SUPPL-76 Labeling

Label is not available on this site.

03/24/1993 SUPPL-75 Labeling

Label is not available on this site.

09/17/1992 SUPPL-74 Labeling

Label is not available on this site.

09/13/1990 SUPPL-73 Labeling

Label is not available on this site.

12/18/1992 SUPPL-72 Labeling

Label is not available on this site.

04/21/1988 SUPPL-71 Labeling

Label is not available on this site.

04/26/1988 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

08/26/1987 SUPPL-69 Labeling

Label is not available on this site.

06/02/1986 SUPPL-68 Labeling

Label is not available on this site.

10/24/1985 SUPPL-67 Labeling

Label is not available on this site.

01/17/1985 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1984 SUPPL-65 Labeling

Label is not available on this site.

08/13/1984 SUPPL-64 Labeling

Label is not available on this site.

04/03/1984 SUPPL-63 Labeling

Label is not available on this site.

04/10/1984 SUPPL-62 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/23/1984 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

12/23/1983 SUPPL-60 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/01/1983 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1982 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

09/08/1982 SUPPL-57 Labeling

Label is not available on this site.

05/08/1987 SUPPL-56 Labeling

Label is not available on this site.

10/14/1981 SUPPL-55 Labeling

Label is not available on this site.

06/17/1981 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/11/1981 SUPPL-52 Labeling

Label is not available on this site.

04/09/1981 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1981 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1981 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1980 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/1980 SUPPL-47 Labeling

Label is not available on this site.

01/03/1980 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/1979 SUPPL-45 Labeling

Label is not available on this site.

10/31/1979 SUPPL-44 Labeling

Label is not available on this site.

03/09/1979 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1981 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1978 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1978 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/1977 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1978 SUPPL-37 Labeling

Label is not available on this site.

09/13/1977 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/13/1977 SUPPL-35 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/13/1977 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.

10/31/1979 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.

08/31/1976 SUPPL-30 Labeling

Label is not available on this site.

03/19/1976 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/12/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

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