Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079079
Company: MATRIX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE; ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG; 300MG TABLET; 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
11/29/2007 ORIG-1 Tentative Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/079079TAs000ltr.pdf

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