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FDA ANDA · ANDA079116

RAMIPRIL

Sponsor: COREPHARMA

APPLICATION
ANDA079116
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-20
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 8 · standardAP
2019-12-09Labeling · Supplement 9 · standardAP
2019-12-09Labeling · Supplement 10 · standardAP
2015-01-24Labeling · Supplement 6 · standardAP
2015-01-24Labeling · Supplement 4 · standardAP
2015-01-24Labeling · Supplement 7 · standardAP
2015-01-24Labeling · Supplement 5 · standardAP
2015-01-24Labeling · Supplement 3 · standardAP
2013-05-07Labeling · Supplement 1AP
2008-06-20Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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