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FDA ANDA · ANDA205823

QUINAPRIL

Sponsor: PRINSTON INC

APPLICATION
ANDA205823
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-15
LATEST ACTION
2019-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEPrescription
QUINAPRIL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2019-11-01Labeling · Supplement 2 · standardAP
2016-09-15UNKNOWN · Original · standardAP
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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