APPLICATION
ANDA091604
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-08
LATEST ACTION
2021-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RAMIPRILPrescription
RAMIPRIL 10MG · CAPSULE · ORAL
RAMIPRILPrescription
RAMIPRIL 2.5MG · CAPSULE · ORAL
RAMIPRILPrescription
RAMIPRIL 5MG · CAPSULE · ORAL
RAMIPRILPrescription
RAMIPRIL 1.25MG · CAPSULE · ORAL
Approval history
2021-10-01Labeling · Supplement 10 · standardAP
2021-04-02Labeling · Supplement 8 · standardAP
2016-03-28Labeling · Supplement 7 · standardAP
2015-02-18Labeling · Supplement 5 · standardAP
2015-02-18Labeling · Supplement 3AP
2015-02-18Labeling · Supplement 6 · standardAP
2015-02-18Labeling · Supplement 4 · standardAP
2011-06-08OriginalAP
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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