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FDA ANDA · ANDA204058
LISINOPRIL AND HYDROCHLOROTHIAZIDE
lisinopril and hydrochlorothiazide tablets
Sponsor: INVAGEN PHARMS
APPLICATION
ANDA204058
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-23
LATEST ACTION
2024-05-31
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
2024-05-31Labeling · Supplement 11 · standardAP
2020-08-07Labeling · Supplement 4 · standardAP
2017-05-23UNKNOWN · Original · standardAP
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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