APPLICATION
NDA013334
TYPE
NDA
ORIGINAL APPROVAL
1962-07-11
LATEST ACTION
1996-03-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DECADRON W/ XYLOCAINEDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML, LIDOCAINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
1996-03-01Manufacturing (CMC) · Supplement 34 · standardAP
1993-08-27Labeling · Supplement 32 · standardAP
1991-02-12Manufacturing (CMC) · Supplement 30 · standardAP
1985-03-08Labeling · Supplement 23 · standardAP
1983-02-21Manufacturing (CMC) · Supplement 21 · standardAP
1982-05-21Labeling · Supplement 18 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 20 · standardAP
1979-07-13Labeling · Supplement 17 · standardAP
1962-07-11Type 4 - New Combination · Original · standardAP
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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