Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021714
Company: DR REDDYS LABS LTD

Products on NDA 021714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	2.5MG; 10MG	CAPSULE; ORAL	None (Tentative Approval)	None	No	No
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	5MG; 10MG	CAPSULE; ORAL	None (Tentative Approval)	None	No	No
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	5MG; 20MG	CAPSULE; ORAL	None (Tentative Approval)	None	No	No
AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE MALEATE; BENAZEPRIL HYDROCHLORIDE	10MG; 20MG	CAPSULE; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2006	ORIG-1	Tentative Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.