APPLICATION
ANDA078745
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-18
LATEST ACTION
2020-07-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RAMIPRILPrescription
RAMIPRIL 5MG · CAPSULE · ORAL
RAMIPRILPrescription
RAMIPRIL 1.25MG · CAPSULE · ORAL
RAMIPRILPrescription
RAMIPRIL 10MG · CAPSULE · ORAL
RAMIPRILPrescription
RAMIPRIL 2.5MG · CAPSULE · ORAL
Approval history
2020-07-24Labeling · Supplement 11 · standardAP
2016-02-28Labeling · Supplement 9 · standardAP
2016-02-28Labeling · Supplement 8 · standardAP
2014-09-26Labeling · Supplement 7 · standardAP
2014-09-26Labeling · Supplement 5 · standardAP
2014-09-26Labeling · Supplement 3AP
2011-05-19Labeling · Supplement 2AP
2009-10-22Labeling · Supplement 1AP
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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