APPLICATION
ANDA215654
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-04
LATEST ACTION
2025-04-03
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
DEXAMETHASONE SODIUM PHOSPHATEPrescription
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML · INJECTABLE · INJECTION
Approval history
2025-04-03Labeling · Supplement 4 · standardAP
2024-06-05Labeling · Supplement 3 · standardAP
2021-08-04UNKNOWN · 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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