← FDA DRUG APPROVALS
FDA ANDA · ANDA076007
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA076007
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2014-02-28
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
2014-02-28Labeling · Supplement 16 · standardAP
2013-08-05Labeling · Supplement 15 · standardAP
2013-08-05Labeling · Supplement 13 · standardAP
2013-08-05Labeling · Supplement 14 · standardAP
2013-08-05Labeling · Supplement 12 · standardAP
2009-09-02Labeling · Supplement 10AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.