Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 011664
Company: MERCK

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECADRON	DEXAMETHASONE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
DECADRON	DEXAMETHASONE	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
DECADRON	DEXAMETHASONE	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
DECADRON	DEXAMETHASONE	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
DECADRON	DEXAMETHASONE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
DECADRON	DEXAMETHASONE	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
05/08/2019	SUPPL-64	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011664s064lbl.pdf
04/23/2018	SUPPL-65	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011664s065lbl.pdf
07/29/2016	SUPPL-63	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011664s063lbl.pdf
05/17/2004	SUPPL-62	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11664slr062_decadron_lbl.pdf