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FDA ANDA · ANDA079135
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA079135
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-05
LATEST ACTION
2020-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDEPrescription
TRANDOLAPRIL 4MG, VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDEPrescription
TRANDOLAPRIL 2MG, VERAPAMIL HYDROCHLORIDE 180MG · TABLET, EXTENDED RELEASE · ORAL
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDEPrescription
TRANDOLAPRIL 1MG, VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDEPrescription
TRANDOLAPRIL 2MG, VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-04-14Labeling · Supplement 8 · standardAP
2020-04-14Labeling · Supplement 9 · standardAP
2020-04-14Labeling · Supplement 7 · standardAP
2020-04-14Labeling · Supplement 11 · standardAP
2015-05-01Labeling · Supplement 6 · standardAP
2015-05-01Labeling · Supplement 4 · standardAP
2015-05-01Labeling · Supplement 5 · standardAP
2010-08-30OriginalAP
2010-05-26OriginalAP
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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