APPLICATION
ANDA087702
TYPE
ANDA
ORIGINAL APPROVAL
1982-09-07
LATEST ACTION
2024-06-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXAMETHASONE SODIUM PHOSPHATEPrescription
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
2024-06-05Labeling · Supplement 50 · standardAP
2020-07-29Labeling · Supplement 41 · standardAP
2020-07-29Labeling · Supplement 39 · standardAP
2014-07-03Labeling · Supplement 36 · standardAP
2003-01-07Manufacturing (CMC) · Supplement 29AP
2001-09-05Manufacturing (CMC) · Supplement 28AP
2000-07-11Manufacturing (CMC) · Supplement 27AP
1999-09-07Manufacturing (CMC) · Supplement 26AP
1998-12-01Manufacturing (CMC) · Supplement 25AP
1998-06-12Manufacturing (CMC) · Supplement 22AP
1998-05-07Manufacturing (CMC) · Supplement 21AP
1995-02-15Labeling · Supplement 20AP
1994-04-19Manufacturing (CMC) · Supplement 19AP
1994-01-27Labeling · Supplement 18AP
1992-01-14Manufacturing (CMC) · Supplement 14AP
1991-10-28Labeling · Supplement 17AP
1991-06-12Labeling · Supplement 16AP
1989-09-21Labeling · Supplement 13AP
1989-05-26Labeling · Supplement 11AP
1989-05-26Labeling · Supplement 12AP
1989-02-07Labeling · Supplement 10AP
1988-03-21Manufacturing (CMC) · Supplement 6AP
1988-03-21Manufacturing (CMC) · Supplement 4AP
1988-03-21Manufacturing (CMC) · Supplement 5AP
1987-04-02Manufacturing (CMC) · Supplement 9AP
1984-11-27Manufacturing (CMC) · Supplement 3AP
1983-01-31Manufacturing (CMC) · Supplement 2AP
1983-01-31Manufacturing (CMC) · Supplement 1AP
1982-09-07OriginalAP
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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