Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761103
Company: PFIZER INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUXIENCE RITUXIMAB-PVVR 100MG/10ML(10MG/ML) INJECTABLE;INJECTION Prescription None No No
RUXIENCE RITUXIMAB-PVVR 500MG/50ML(10MG/ML) 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
07/23/2019 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761103Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/26/2020 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761103Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/26/2020 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf
07/23/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf

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