Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204914
Company: MYLAN LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE; ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 30MG; 60MG TABLET; ORAL SUSPENSION 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
02/04/2014 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204914Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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