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FDA ANDA · ANDA202725
QUINAPRIL
quinapril hydrochloride
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA202725
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-29
LATEST ACTION
2022-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2022-03-31Labeling · Supplement 13 · standardAP
2018-06-08Labeling · Supplement 8 · standardAP
2018-06-08Labeling · Supplement 7 · standardAP
2015-11-24Labeling · Supplement 6 · standardAP
2015-11-24Labeling · Supplement 5 · standardAP
2014-09-26Labeling · Supplement 3 · standardAP
2014-09-26Labeling · Supplement 2 · standardAP
2013-04-29UNKNOWN · OriginalAP
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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