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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
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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