APPLICATION
ANDA215307
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-22
LATEST ACTION
2024-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIGOXINPrescription
DIGOXIN 0.0625MG · TABLET · ORAL
DIGOXINPrescription
DIGOXIN 0.125MG · TABLET · ORAL
DIGOXINPrescription
DIGOXIN 0.25MG · TABLET · ORAL
Approval history
2024-11-19Labeling · Supplement 9 · standardAP
2021-11-22UNKNOWN · 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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