APPLICATION
ANDA077912
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-27
LATEST ACTION
2023-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL
Approval history
2023-03-17Labeling · Supplement 43 · standardAP
2023-03-17Labeling · Supplement 35 · standardAP
2023-03-17Labeling · Supplement 33 · standardAP
2023-03-17Labeling · Supplement 28 · standardAP
2014-02-28Labeling · Supplement 20 · standardAP
2014-02-28Labeling · Supplement 19AP
2014-02-28Labeling · Supplement 23 · standardAP
2009-08-31Labeling · Supplement 8AP
2007-01-11Labeling · Supplement 1AP
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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