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FDA ANDA · ANDA077900

RAMIPRIL

Sponsor: HIKMA

APPLICATION
ANDA077900
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-18
LATEST ACTION
2019-12-09
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

2019-12-09Labeling · Supplement 14 · standardAP
2019-12-09Labeling · Supplement 13 · standardAP
2014-09-26Labeling · Supplement 6 · standardAP
2014-09-26Labeling · Supplement 10 · standardAP
2014-09-26Labeling · Supplement 9 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 7AP
2014-09-26Labeling · Supplement 5AP
2011-01-12Labeling · Supplement 4AP
2010-12-27Labeling · Supplement 3AP
2009-10-22Labeling · Supplement 1AP
2008-06-18Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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