Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209196
Company: SANOFI-AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADMELOG INSULIN LISPRO 1000 UNITS/10ML (100 UNITS/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes No
ADMELOG INSULIN LISPRO 300 UNITS/3ML (100 UNITS/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes No
ADMELOG SOLOSTAR INSULIN LISPRO 300 UNITS/3ML (100 UNITS/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes 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
12/11/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209196Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209196Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209196Orig1s002ltr.pdf
10/19/2018 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf
12/11/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf

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