APPLICATION
ANDA074225
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-24
LATEST ACTION
2020-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUMETANIDEPrescription
BUMETANIDE 1MG · TABLET · ORAL
BUMETANIDEPrescription
BUMETANIDE 2MG · TABLET · ORAL
BUMETANIDEPrescription
BUMETANIDE 0.5MG · TABLET · ORAL
Approval history
2020-04-06Labeling · Supplement 21 · standardAP
2020-04-06Labeling · Supplement 19 · standardAP
2010-03-03Labeling · Supplement 17AP
2008-09-03Labeling · Supplement 16AP
2005-01-21Labeling · Supplement 9AP
2002-07-29Manufacturing (CMC) · Supplement 5AP
2002-03-12Manufacturing (CMC) · Supplement 4AP
2002-02-21Manufacturing (CMC) · Supplement 3AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1999-01-14Labeling · Supplement 1AP
1995-04-24OriginalAP
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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