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FDA ANDA · ANDA076483

FOSINOPRIL SODIUM

Sponsor: CHARTWELL RX

APPLICATION
ANDA076483
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-23
LATEST ACTION
2013-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 20MG · TABLET · ORAL
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 40MG · TABLET · ORAL
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 10MG · TABLET · ORAL

Approval history

2013-12-31Labeling · Supplement 7AP
2013-12-31Labeling · Supplement 13 · standardAP
2004-04-23OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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