APPLICATION
ANDA209192
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-06
LATEST ACTION
2026-07-17
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
2026-07-17Labeling · Supplement 5 · standardAP
2024-06-05Labeling · Supplement 4 · standardAP
2021-11-18Labeling · Supplement 3 · standardAP
2018-07-06UNKNOWN · 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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