APPLICATION
ANDA074299
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-27
LATEST ACTION
2023-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
INDAPAMIDEPrescription
INDAPAMIDE 2.5MG · TABLET · ORAL
INDAPAMIDEPrescription
INDAPAMIDE 1.25MG · TABLET · ORAL
Approval history
2023-09-28Labeling · Supplement 30 · standardAP
2017-09-22Manufacturing (CMC) · Supplement 27 · unknownAP
2001-09-12Manufacturing (CMC) · Supplement 20AP
2001-08-28Manufacturing (CMC) · Supplement 19AP
2001-08-28Manufacturing (CMC) · Supplement 18AP
2000-08-01Manufacturing (CMC) · Supplement 13AP
2000-08-01Manufacturing (CMC) · Supplement 14AP
2000-06-23Manufacturing (CMC) · Supplement 17AP
2000-06-23Manufacturing (CMC) · Supplement 16AP
2000-03-28Manufacturing (CMC) · Supplement 15AP
2000-03-21Manufacturing (CMC) · Supplement 12AP
2000-01-28Manufacturing (CMC) · Supplement 11AP
1999-11-23Manufacturing (CMC) · Supplement 10AP
1999-10-29Manufacturing (CMC) · Supplement 9AP
1999-02-01Manufacturing (CMC) · Supplement 8AP
1998-12-09Manufacturing (CMC) · Supplement 7AP
1997-10-21Labeling · Supplement 6AP
1997-05-30Manufacturing (CMC) · Supplement 5AP
1997-04-16Manufacturing (CMC) · Supplement 4AP
1996-04-29Labeling · Supplement 2AP
1996-04-29Manufacturing (CMC) · Supplement 3AP
1996-04-29Manufacturing (CMC) · Supplement 1AP
1995-07-27OriginalAP
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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