Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125545
Company: HOSPIRA INC
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 |