APPLICATION
ANDA089169
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-09
LATEST ACTION
2024-06-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXAMETHASONE SODIUM PHOSPHATEDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
2024-06-05Labeling · Supplement 21 · standardAP
2014-12-02Labeling · Supplement 20 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 18AP
1999-02-02Manufacturing (CMC) · Supplement 17AP
1997-09-15Manufacturing (CMC) · Supplement 16AP
1996-12-04Manufacturing (CMC) · Supplement 15AP
1995-07-17Labeling · Supplement 14AP
1994-02-16Labeling · Supplement 13AP
1993-12-13Labeling · Supplement 12AP
1993-09-23Labeling · Supplement 11AP
1988-08-02Manufacturing (CMC) · Supplement 6AP
1988-08-02Manufacturing (CMC) · Supplement 5AP
1988-08-01Bioequivalence · Supplement 8AP
1986-10-15Manufacturing (CMC) · Supplement 2AP
1986-08-19Manufacturing (CMC) · Supplement 1AP
1986-04-09OriginalAP
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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