Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021435
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMVAZ AMLODIPINE MALEATE 2.5MG TABLET;ORAL Discontinued None No No
AMVAZ AMLODIPINE MALEATE 5MG TABLET;ORAL Discontinued None No No
AMVAZ AMLODIPINE MALEATE 10MG TABLET;ORAL Discontinued 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
10/31/2003 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21435ltr.pdf

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