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FDA ANDA · ANDA087440

DEXAMETHASONE SODIUM PHOSPHATE

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APPLICATION
ANDA087440
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-21
LATEST ACTION
2014-07-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DEXAMETHASONE SODIUM PHOSPHATE · ReferenceDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML · INJECTABLE · INJECTION

Approval history

2014-07-03Labeling · Supplement 27 · standardAP
2001-08-31Manufacturing (CMC) · Supplement 20AP
2001-05-07Manufacturing (CMC) · Supplement 19AP
1997-09-17Manufacturing (CMC) · Supplement 18AP
1996-09-16Labeling · Supplement 17AP
1996-02-28Manufacturing (CMC) · Supplement 16AP
1995-10-27Labeling · Supplement 14AP
1993-03-11Manufacturing (CMC) · Supplement 15AP
1991-01-16Manufacturing (CMC) · Supplement 11AP
1991-01-16Manufacturing (CMC) · Supplement 12AP
1989-10-02Labeling · Supplement 13AP
1988-04-08Manufacturing (CMC) · Supplement 10AP
1988-04-07Manufacturing (CMC) · Supplement 9AP
1984-09-14Manufacturing (CMC) · Supplement 6AP
1984-09-14Manufacturing (CMC) · Supplement 5AP
1983-05-09Manufacturing (CMC) · Supplement 4AP
1983-05-09Manufacturing (CMC) · Supplement 3AP
1983-05-09Manufacturing (CMC) · Supplement 1AP
1982-07-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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