APPLICATION
ANDA088469
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-25
LATEST ACTION
1994-02-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXAMETHASONEDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
1994-02-08Labeling · Supplement 12AP
1993-07-02Labeling · Supplement 10AP
1991-12-03Labeling · Supplement 9AP
1991-08-07Manufacturing (CMC) · Supplement 8AP
1991-05-30Labeling · Supplement 7AP
1988-05-16Manufacturing (CMC) · Supplement 5AP
1987-06-18Manufacturing (CMC) · Supplement 4AP
1984-07-10Manufacturing (CMC) · Supplement 1AP
1984-01-25OriginalAP
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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