APPLICATION
NDA011664
TYPE
NDA
ORIGINAL APPROVAL
1958-10-30
LATEST ACTION
2019-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DECADRON · ReferenceDiscontinued
DEXAMETHASONE 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DECADRON · ReferenceDiscontinued
DEXAMETHASONE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DECADRON · ReferenceDiscontinued
DEXAMETHASONE 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DECADRON · ReferenceDiscontinued
DEXAMETHASONE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DECADRON · ReferenceDiscontinued
DEXAMETHASONE 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DECADRON · ReferenceDiscontinued
DEXAMETHASONE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-06-25Manufacturing (CMC) · Supplement 60 · priorityAP
1999-02-19Manufacturing (CMC) · Supplement 58 · priorityAP
1998-05-14Manufacturing (CMC) · Supplement 55 · priorityAP
1998-02-26Manufacturing (CMC) · Supplement 57 · priorityAP
1996-03-01Manufacturing (CMC) · Supplement 53 · priorityAP
1993-08-25Labeling · Supplement 50 · standardAP
1989-05-16Labeling · Supplement 44AP
1988-05-03Manufacturing (CMC) · Supplement 47 · priorityAP
1985-11-26Labeling · Supplement 45AP
1984-05-03Manufacturing (CMC) · Supplement 41 · priorityAP
1983-05-11Manufacturing (CMC) · Supplement 43 · priorityAP
1983-03-22Manufacturing (CMC) · Supplement 42 · priorityAP
1982-07-30Labeling · Supplement 36AP
1982-07-30Manufacturing (CMC) · Supplement 21 · priorityAP
1982-02-10Manufacturing (CMC) · Supplement 37 · priorityAP
1981-04-01Labeling · Supplement 38AP
1980-04-23Manufacturing (CMC) · Supplement 35 · priorityAP
1980-02-05Manufacturing (CMC) · Supplement 32 · priorityAP
1980-02-04Labeling · Supplement 34AP
1980-02-04Labeling · Supplement 33AP
1979-10-26Manufacturing (CMC) · Supplement 26 · priorityAP
1979-09-24Manufacturing (CMC) · Supplement 30 · priorityAP
1979-08-15Labeling · Supplement 31AP
1979-07-26Labeling · Supplement 28AP
1979-07-26Labeling · Supplement 24AP
1979-07-26Labeling · Supplement 29AP
1979-07-26Labeling · Supplement 27AP
1978-10-11Manufacturing (CMC) · Supplement 25 · priorityAP
1958-10-30Type 1 - New Molecular Entity · Original · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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