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FDA ANDA · ANDA076230
LISINOPRIL AND HYDROCHLOROTHIAZIDE
lisinopril and hydrochlorothiazide tablets
Sponsor: PRINSTON INC
APPLICATION
ANDA076230
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 19 · standardAP
2004-10-20Labeling · Supplement 5AP
2003-05-13Labeling · Supplement 2AP
2002-07-01OriginalAP
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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