Drugs@FDA: FDA Approved Drug Products

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

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