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FDA ANDA · ANDA078832

RAMIPRIL

Sponsor: ZYDUS PHARMS USA

APPLICATION
ANDA078832
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-02
LATEST ACTION
2022-06-30
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

2022-06-30Labeling · Supplement 17 · standardAP
2021-04-02Labeling · Supplement 16 · standardAP
2016-01-22Labeling · Supplement 13 · standardAP
2014-09-26Labeling · Supplement 6 · standardAP
2014-09-26Labeling · Supplement 4 · standardAP
2014-09-26Labeling · Supplement 9 · standardAP
2014-09-26Labeling · Supplement 7 · standardAP
2011-03-15Labeling · Supplement 1AP
2008-09-02Original — 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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