Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013401
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDOMET METHYLDOPATE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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 2 - New Active Ingredient 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
08/05/1997 SUPPL-47 Labeling

Label is not available on this site.

08/05/1997 SUPPL-46 Labeling

Label is not available on this site.

11/29/1995 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/16/1994 SUPPL-44 Labeling

Label is not available on this site.

03/24/1993 SUPPL-43 Labeling

Label is not available on this site.

09/13/1990 SUPPL-42 Labeling

Label is not available on this site.

11/06/1989 SUPPL-41 Labeling

Label is not available on this site.

05/11/1987 SUPPL-40 Labeling

Label is not available on this site.

02/22/1985 SUPPL-39 Labeling

Label is not available on this site.

10/11/1984 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1985 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1984 SUPPL-36 Labeling

Label is not available on this site.

03/01/1984 SUPPL-35 Labeling

Label is not available on this site.

09/08/1982 SUPPL-34 Labeling

Label is not available on this site.

11/06/1989 SUPPL-33 Labeling

Label is not available on this site.

10/14/1981 SUPPL-32 Labeling

Label is not available on this site.

07/14/1981 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1981 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/01/1981 SUPPL-29 Labeling

Label is not available on this site.

03/25/1981 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1979 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1979 SUPPL-23 Labeling

Label is not available on this site.

11/09/1976 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1976 SUPPL-20 Labeling

Label is not available on this site.

01/06/1976 SUPPL-19 Labeling

Label is not available on this site.

07/11/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1975 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1975 SUPPL-13 Unspecified

Label is not available on this site.

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