Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761074
Company: MYLAN GMBH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OGIVRI TRASTUZUMAB-DKST 420MG/VIAL INJECTABLE;INJECTION Prescription None TBD 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
12/01/2017 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761074s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761074Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2019 SUPPL-5 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761074Orig1s005ltr.pdf
04/17/2019 SUPPL-4 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s004lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2019 SUPPL-4 Manufacturing (CMC)-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s004lbl.pdf
12/01/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761074s000lbl.pdf

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