APPLICATION
ANDA076188
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-08
LATEST ACTION
2016-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FOSINOPRIL SODIUMDiscontinued
FOSINOPRIL SODIUM 20MG · TABLET · ORAL
FOSINOPRIL SODIUMDiscontinued
FOSINOPRIL SODIUM 40MG · TABLET · ORAL
FOSINOPRIL SODIUMDiscontinued
FOSINOPRIL SODIUM 10MG · TABLET · ORAL
Approval history
2016-01-13Labeling · Supplement 1 · standardAP
2004-10-08OriginalAP
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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