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FDA NDA · NDA021714
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE
Sponsor: DR REDDYS LABS LTD
APPLICATION
NDA021714
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
None (Tentative Approval)
Products
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDENone (Tentative Approval)
AMLODIPINE MALEATE 5MG, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDENone (Tentative Approval)
AMLODIPINE MALEATE 2.5MG, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDENone (Tentative Approval)
AMLODIPINE MALEATE 10MG, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDENone (Tentative Approval)
AMLODIPINE MALEATE 5MG, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2006-09-15Type 4 - New Combination · Original · standardTA
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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