APPLICATION
ANDA084315
TYPE
ANDA
ORIGINAL APPROVAL
1978-11-08
LATEST ACTION
2014-12-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXAMETHASONE ACETATEDiscontinued
DEXAMETHASONE ACETATE EQ 8MG BASE/ML · INJECTABLE · INJECTION
Approval history
2014-12-02Labeling · Supplement 118 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 116AP
1999-02-02Manufacturing (CMC) · Supplement 115AP
1998-05-22Manufacturing (CMC) · Supplement 114AP
1995-10-20Labeling · Supplement 113AP
1994-03-21Labeling · Supplement 112AP
1993-12-20Manufacturing (CMC) · Supplement 111AP
1992-05-11Manufacturing (CMC) · Supplement 110AP
1991-03-19Manufacturing (CMC) · Supplement 108AP
1991-03-19Manufacturing (CMC) · Supplement 107AP
1989-11-08Labeling · Supplement 109AP
1988-12-23Manufacturing (CMC) · Supplement 104AP
1988-12-23Manufacturing (CMC) · Supplement 105AP
1986-06-16Manufacturing (CMC) · Supplement 98AP
1983-07-25Manufacturing (CMC) · Supplement 95AP
1982-10-15Manufacturing (CMC) · Supplement 93AP
1978-11-08OriginalAP
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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