Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761075
Company: MYLAN GMBH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FULPHILA PEGFILGRASTIM-JMDB 6MG/0.6ML 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
06/04/2018 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761075s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761075Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2019 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761075Orig1s004ltr.pdf
03/21/2019 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761075Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/29/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s004lbl.pdf
03/21/2019 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s001lbl.pdf
06/04/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761075s000lbl.pdf

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