APPLICATION
ANDA084916
TYPE
ANDA
ORIGINAL APPROVAL
1977-09-06
LATEST ACTION
2024-06-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXAMETHASONE SODIUM PHOSPHATE · ReferencePrescription
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
2024-06-05Labeling · Supplement 75 · standardAP
2020-07-28Labeling · Supplement 69 · standardAP
2020-07-28Labeling · Supplement 65 · standardAP
2002-12-05Manufacturing (CMC) · Supplement 57AP
2001-06-13Manufacturing (CMC) · Supplement 56AP
1995-07-20Labeling · Supplement 54AP
1994-01-11Labeling · Supplement 53AP
1991-09-13Manufacturing (CMC) · Supplement 51AP
1991-06-13Labeling · Supplement 52AP
1991-02-06Labeling · Supplement 50AP
1989-07-12Labeling · Supplement 48AP
1988-11-02Labeling · Supplement 47AP
1986-06-13Manufacturing (CMC) · Supplement 43AP
1985-01-03Manufacturing (CMC) · Supplement 39AP
1985-01-03Manufacturing (CMC) · Supplement 38AP
1984-12-06Manufacturing (CMC) · Supplement 40AP
1984-01-17Manufacturing (CMC) · Supplement 35AP
1983-12-06Manufacturing (CMC) · Supplement 34AP
1982-04-19Manufacturing (CMC) · Supplement 30AP
1977-09-06OriginalAP
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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