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FDA ANDA · ANDA078191

RAMIPRIL

Sponsor: SENORES PHARMS

APPLICATION
ANDA078191
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-18
LATEST ACTION
2014-09-26
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

2014-09-26Labeling · Supplement 3AP
2011-02-03Labeling · Supplement 2AP
2011-01-12Labeling · Supplement 1AP
2008-06-18OriginalOther Important Information from FDAAP
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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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