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FDA ANDA · ANDA090747
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE
Sponsor: AM REGENT
APPLICATION
ANDA090747
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-31
LATEST ACTION
2025-09-16
ROUTE
INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, 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
2025-09-16Labeling · Supplement 26 · standardAP
2025-09-16Labeling · Supplement 10 · standardAP
2022-01-13Manufacturing (CMC) · Supplement 18 · unknownAP
2016-04-19Labeling · Supplement 4 · standardAP
2016-04-19Labeling · Supplement 5 · standardAP
2009-07-31OriginalAP
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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