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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761179
Company: JAZZ PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYLAZE ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN 10MG/0.5ML INJECTABLE;INTRAMUSCULAR 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
06/30/2021 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761179s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761179Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761179Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2021 SUPPL-2 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/30/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761179s000lbledt.pdf
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