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FDA ANDA · ANDA077626

RAMIPRIL

Sponsor: LUPIN

APPLICATION
ANDA077626
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-09
LATEST ACTION
2022-06-30
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

2022-06-30Labeling · Supplement 25 · standardAP
2021-04-02Labeling · Supplement 21 · standardAP
2016-02-16Labeling · Supplement 18 · standardAP
2015-08-31Manufacturing (CMC) · Supplement 17 · unknownAP
2014-09-26Labeling · Supplement 15 · standardAP
2014-09-26Labeling · Supplement 13 · standardAP
2014-09-26Labeling · Supplement 14 · standardAP
2014-09-26Labeling · Supplement 9AP
2009-10-29Labeling · Supplement 4AP
2008-08-22Labeling · Supplement 1AP
2008-06-09Original — 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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