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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761082
Company: KASHIV BIOSCIENCES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RELEUKO FILGRASTIM-AYOW 300MCG/ML/VIAL SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription None No No
RELEUKO FILGRASTIM-AYOW 480MCG/1.6ML/VIAL SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription None No No
RELEUKO FILGRASTIM-AYOW 300MCG/0.5ML SOLUTION;SUBCUTANEOUS Prescription None No No
RELEUKO FILGRASTIM-AYOW 480MCG/0.8ML SOLUTION;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
02/25/2022 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761082Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2022 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761082Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/28/2022 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf
10/28/2022 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf
10/28/2022 SUPPL-3 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf
02/25/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s000lbl.pdf
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