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FDA ANDA · ANDA077838
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
Sponsor: HIKMA
APPLICATION
ANDA077838
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-17
LATEST ACTION
2025-03-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEPrescription
BETAMETHASONE ACETATE 3MG/ML, BETAMETHASONE SODIUM PHOSPHATE EQ 3MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-03-28Labeling · Supplement 3 · standardAP
2023-01-17OriginalAP
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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