APPLICATION
ANDA084282
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-15
LATEST ACTION
2024-06-05
ROUTE
INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXAMETHASONE SODIUM PHOSPHATEPrescription
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
2024-06-05Labeling · Supplement 59 · standardAP
2020-07-29Labeling · Supplement 48 · standardAP
2016-10-25Labeling · Supplement 46 · standardAP
2000-07-11Manufacturing (CMC) · Supplement 44AP
1999-09-07Manufacturing (CMC) · Supplement 43AP
1998-12-01Manufacturing (CMC) · Supplement 42AP
1998-06-16Manufacturing (CMC) · Supplement 37AP
1998-06-12Manufacturing (CMC) · Supplement 39AP
1998-05-07Manufacturing (CMC) · Supplement 38AP
1995-02-15Labeling · Supplement 35AP
1995-01-05Manufacturing (CMC) · Supplement 36AP
1994-01-27Labeling · Supplement 34AP
1992-08-28Manufacturing (CMC) · Supplement 33AP
1991-12-31Labeling · Supplement 32AP
1991-10-28Labeling · Supplement 31AP
1991-06-12Labeling · Supplement 29AP
1991-06-12Manufacturing (CMC) · Supplement 27AP
1989-10-05Manufacturing (CMC) · Supplement 28AP
1989-03-15Labeling · Supplement 26AP
1989-02-17Labeling · Supplement 25AP
1988-09-07Labeling · Supplement 24AP
1988-01-11Manufacturing (CMC) · Supplement 19AP
1988-01-11Manufacturing (CMC) · Supplement 17AP
1988-01-11Manufacturing (CMC) · Supplement 18AP
1985-10-22Manufacturing (CMC) · Supplement 21AP
1984-12-07Manufacturing (CMC) · Supplement 16AP
1983-02-17Manufacturing (CMC) · Supplement 15AP
1983-02-17Manufacturing (CMC) · Supplement 14AP
1975-07-15OriginalAP
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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