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Drugs@FDA: FDA-Approved Drugs

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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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2024 SUPPL-32 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125545s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125545Orig1s032ltr.pdf
04/18/2023 SUPPL-22 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125545Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125545Orig1s022ltr.pdf
06/30/2020 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125545Orig1s005ltr.pdf
01/18/2019 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125545Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/04/2024 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125545s032lbl.pdf
04/18/2023 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125545Orig1s022lbl.pdf
06/30/2020 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf
01/18/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf
05/15/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf
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