Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 211284
Company: CELLTRION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMIXYS LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 300MG;300MG TABLET;ORAL Prescription 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
11/16/2018 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211284s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211284Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211284Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211284s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211284Orig1s002ltr.pdf
04/10/2019 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211284Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2019 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211284s002lbl.pdf
10/29/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211284s002lbl.pdf
10/29/2019 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211284s002lbl.pdf
11/16/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211284s000lbl.pdf

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