Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | INJECTABLE;INJECTION | 2,000UNITS/ML | 0 | RETACRIT | EPOETIN ALFA-EPBX |
| 002 | INJECTABLE;INJECTION | 3,000UNITS/ML | 0 | RETACRIT | EPOETIN ALFA-EPBX |
| 003 | INJECTABLE;INJECTION | 4,000UNITS/ML | 0 | RETACRIT | EPOETIN ALFA-EPBX |
| 004 | INJECTABLE;INJECTION | 10,000UNITS/ML | 0 | RETACRIT | EPOETIN ALFA-EPBX |
| 005 | INJECTABLE;INJECTION | 40,000UNITS/ML | 0 | RETACRIT | EPOETIN ALFA-EPBX |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2018-05-15 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-01-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2020-06-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 15 |
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 125545
[companyName] => HOSPIRA INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125545s005lbl.pdf#page=31"]
[products] => [{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"2,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"3,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"4,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"10,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"40,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125545s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125545s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125545s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125545s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125545Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/125545Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125545s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125545Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125545s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125545Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-30
)
)