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FDA ANDA · ANDA214982

DIGOXIN

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA214982
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-08
LATEST ACTION
2024-08-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DIGOXINPrescription
DIGOXIN 0.125MG · TABLET · ORAL
DIGOXINPrescription
DIGOXIN 0.25MG · TABLET · ORAL
DIGOXINPrescription
DIGOXIN 0.0625MG · TABLET · ORAL

Approval history

2024-08-21Labeling · Supplement 1 · standardAP
2022-02-08UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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