APPLICATION
ANDA074722
TYPE
ANDA
ORIGINAL APPROVAL
1996-06-17
LATEST ACTION
2022-07-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
INDAPAMIDEPrescription
INDAPAMIDE 2.5MG · TABLET · ORAL
INDAPAMIDEPrescription
INDAPAMIDE 1.25MG · TABLET · ORAL
Approval history
2022-07-06Labeling · Supplement 34 · standardAP
2013-02-05Labeling · Supplement 27 · standardAP
2002-01-22Manufacturing (CMC) · Supplement 8AP
2002-01-22Manufacturing (CMC) · Supplement 7AP
2001-11-02Manufacturing (CMC) · Supplement 6AP
2001-06-21Labeling · Supplement 5AP
1998-08-03Manufacturing (CMC) · Supplement 4AP
1998-03-12Manufacturing (CMC) · Supplement 3AP
1997-07-16Manufacturing (CMC) · Supplement 1AP
1997-06-23Labeling · Supplement 2AP
1996-06-17OriginalAP
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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