APPLICATION
NDA016675
TYPE
NDA
ORIGINAL APPROVAL
1973-09-06
LATEST ACTION
1996-03-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DECADRON-LA · ReferenceDiscontinued
DEXAMETHASONE ACETATE EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1996-03-01Manufacturing (CMC) · Supplement 32 · standardAP
1993-08-27Labeling · Supplement 28 · standardAP
1989-12-11Manufacturing (CMC) · Supplement 27 · standardAP
1989-05-16Labeling · Supplement 19 · standardAP
1985-03-08Labeling · Supplement 20 · standardAP
1983-02-21Manufacturing (CMC) · Supplement 18 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 16 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 15 · standardAP
1981-12-03Manufacturing (CMC) · Supplement 13 · standardAP
1979-08-08Labeling · Supplement 12 · standardAP
1973-09-06Type 2 - New Active Ingredient · 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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