ADMELOG از شرکت SANOFI-AVENTIS US

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ADMELOG از شرکت SANOFI-AVENTIS US

Biologic License Application (BLA): 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

No No
ADMELOG INSULIN LISPRO 300 UNITS/3ML (100 UNITS/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription

None

No No
ADMELOG SOLOSTAR INSULIN LISPRO 300 UNITS/3ML (100 UNITS/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS 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
12/11/2017 ORIG-1 Approval

N/A

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
11/15/2019 SUPPL-5 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf

11/15/2019 SUPPL-4 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf

11/01/2018 SUPPL-2 Supplement

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 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-5

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf
11/15/2019 SUPPL-4

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf
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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