Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Biologic License Application (BLA): 125477
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYRAMZA RAMUCIRUMAB 100MG/10ML INJECTABLE;INJECTION Prescription None No No
CYRAMZA RAMUCIRUMAB 500MG/50ML INJECTABLE;INJECTION 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
04/21/2014 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2019 SUPPL-35 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s035ltr.pdf
07/31/2019 SUPPL-33 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s033ltr.pdf
11/26/2018 SUPPL-31 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s031ltr.pdf
08/14/2018 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s030REPLACEMENT LETTER.pdf
05/10/2019 SUPPL-29 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s029ltr.pdf
04/24/2015 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125477Orig1s011ltr.pdf
12/12/2014 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s007ltr.pdf
11/05/2014 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf
08/14/2018 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf
04/24/2015 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf
12/12/2014 SUPPL-7 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf
11/05/2014 SUPPL-2 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf
04/21/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English