APPLICATION
ANDA074461
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-27
LATEST ACTION
2024-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
INDAPAMIDEPrescription
INDAPAMIDE 1.25MG · TABLET · ORAL
INDAPAMIDEPrescription
INDAPAMIDE 2.5MG · TABLET · ORAL
Approval history
2024-08-23Labeling · Supplement 16 · standardAP
2010-01-25Labeling · Supplement 14AP
2002-11-08Manufacturing (CMC) · Supplement 8AP
2002-03-25Labeling · Supplement 7AP
2001-06-14Manufacturing (CMC) · Supplement 6AP
1999-12-20Manufacturing (CMC) · Supplement 4AP
1998-05-15Manufacturing (CMC) · Supplement 3AP
1997-03-26Labeling · Supplement 2AP
1997-03-26Manufacturing (CMC) · Supplement 1AP
1996-03-27OriginalAP
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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