Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013400
Company: MERCK

Products on NDA 13400

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ALDOMET	METHYLDOPA	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ALDOMET	METHYLDOPA	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ALDOMET	METHYLDOPA	125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 013400

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