Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125545
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETACRIT EPOETIN ALFA-EPBX 2,000UNITS/ML INJECTABLE;INJECTION Prescription None No No
RETACRIT EPOETIN ALFA-EPBX 3,000UNITS/ML INJECTABLE;INJECTION Prescription None No No
RETACRIT EPOETIN ALFA-EPBX 4,000UNITS/ML INJECTABLE;INJECTION Prescription None No No
RETACRIT EPOETIN ALFA-EPBX 10,000UNITS/ML INJECTABLE;INJECTION Prescription None No No
RETACRIT EPOETIN ALFA-EPBX 40,000UNITS/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
05/15/2018 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125545Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125545Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/15/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf

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