APPLICATION
ANDA087668
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-01
LATEST ACTION
2024-06-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXAMETHASONE SODIUM PHOSPHATEDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
2024-06-05Labeling · Supplement 26 · standardAP
2014-12-02Labeling · Supplement 25 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 23AP
1999-02-02Manufacturing (CMC) · Supplement 22AP
1998-01-20Manufacturing (CMC) · Supplement 21AP
1997-09-15Manufacturing (CMC) · Supplement 20AP
1996-12-04Manufacturing (CMC) · Supplement 19AP
1994-11-30Labeling · Supplement 18AP
1994-02-14Labeling · Supplement 17AP
1991-12-03Labeling · Supplement 16AP
1989-10-26Manufacturing (CMC) · Supplement 11AP
1989-10-26Labeling · Supplement 12AP
1989-10-26Manufacturing (CMC) · Supplement 10AP
1988-12-23Manufacturing (CMC) · Supplement 13AP
1988-12-23Manufacturing (CMC) · Supplement 14AP
1986-06-16Manufacturing (CMC) · Supplement 6AP
1986-01-22Manufacturing (CMC) · Supplement 4AP
1986-01-22Manufacturing (CMC) · Supplement 5AP
1984-11-20Manufacturing (CMC) · Supplement 2AP
1982-07-01OriginalAP
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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