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FDA ANDA · ANDA076980

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: TEVA

APPLICATION
ANDA076980
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-07
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, MOEXIPRIL HYDROCHLORIDE 15MG · TABLET · ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, MOEXIPRIL HYDROCHLORIDE 15MG · TABLET · ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, MOEXIPRIL HYDROCHLORIDE 7.5MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 15 · standardAP
2013-12-13Manufacturing (CMC) · Supplement 11AP
2013-12-13Labeling · Supplement 9AP
2011-10-31Labeling · Supplement 8AP
2011-06-29Labeling · Supplement 6AP
2011-06-29Labeling · Supplement 4AP
2007-03-07OriginalAP
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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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