APPLICATION
ANDA075201
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-04
LATEST ACTION
2023-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
INDAPAMIDEDiscontinued
INDAPAMIDE 2.5MG · TABLET · ORAL
INDAPAMIDEDiscontinued
INDAPAMIDE 1.25MG · TABLET · ORAL
Approval history
2023-10-16Labeling · Supplement 11 · standardAP
2016-08-02Manufacturing (CMC) · Supplement 3 · unknownAP
2004-02-04Labeling · Supplement 2AP
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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