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Drugs@FDA: FDA-Approved Drugs

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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DECADRON DEXAMETHASONE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DECADRON DEXAMETHASONE 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DECADRON DEXAMETHASONE 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DECADRON DEXAMETHASONE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DECADRON DEXAMETHASONE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DECADRON DEXAMETHASONE 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1958 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/23/2018 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011664s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011664Orig1s065_ltr.pdf
05/08/2019 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011664s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011664Orig1s064ltr.pdf
07/29/2016 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011664s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011664Orig1s063ltr.pdf
05/17/2004 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11664slr062_decadron_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11664slr062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/011664_S062_DECADRON.pdf
06/25/2002 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.
02/19/1999 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.
02/26/1998 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/14/1998 SUPPL-55 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/01/1996 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.
08/25/1993 SUPPL-50 Labeling

Label is not available on this site.
05/03/1988 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
11/26/1985 SUPPL-45 Labeling

Label is not available on this site.
05/16/1989 SUPPL-44 Labeling

Label is not available on this site.
05/11/1983 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
03/22/1983 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
05/03/1984 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.
04/01/1981 SUPPL-38 Labeling

Label is not available on this site.
02/10/1982 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/30/1982 SUPPL-36 Labeling

Label is not available on this site.
04/23/1980 SUPPL-35 Manufacturing (CMC)-Formulation

Label is not available on this site.
02/04/1980 SUPPL-34 Labeling

Label is not available on this site.
02/04/1980 SUPPL-33 Labeling

Label is not available on this site.
02/05/1980 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
08/15/1979 SUPPL-31 Labeling

Label is not available on this site.
09/24/1979 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
07/26/1979 SUPPL-29 Labeling

Label is not available on this site.
07/26/1979 SUPPL-28 Labeling

Label is not available on this site.
07/26/1979 SUPPL-27 Labeling

Label is not available on this site.
10/26/1979 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/11/1978 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
07/26/1979 SUPPL-24 Labeling

Label is not available on this site.
07/30/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note 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
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