Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204806
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATAZANAVIR SULFATE ATAZANAVIR SULFATE 100MG CAPSULE; ORAL None (Tentative Approval) None No No
ATAZANAVIR SULFATE ATAZANAVIR SULFATE 150MG CAPSULE; ORAL None (Tentative Approval) None No No
ATAZANAVIR SULFATE ATAZANAVIR SULFATE 200MG CAPSULE; ORAL None (Tentative Approval) None No No
ATAZANAVIR SULFATE ATAZANAVIR SULFATE 300MG 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
01/31/2014 ORIG-1 Tentative Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204806Orig1s000TAltr.pdf

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