Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | 0 | TRUXIMA | RITUXIMAB-ABBS |
| 002 | INJECTABLE;INJECTION | 500MG/50ML(10MG/ML) | 0 | TRUXIMA | RITUXIMAB-ABBS |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2018-11-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2019-05-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2019-12-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2019-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-02-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 18 | Null | 7 |
CDER Filings
CELLTRION INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761088
[companyName] => CELLTRION INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761088s009lbl.pdf#page=48"]
[products] => [{"drugName":"TRUXIMA","activeIngredients":"RITUXIMAB-ABBS","strength":"100MG\/10ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"TRUXIMA","activeIngredients":"RITUXIMAB-ABBS","strength":"500MG\/50ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761088s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761088s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088s005s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088s005s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088Orig1s001s002_Replacementlbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088Orig1s001s002_Replacementlbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761088s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761088s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761088Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761088Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761088s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761088Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2019","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088s005s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/18\/2019","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088s005s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"05\/23\/2019","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088Orig1s001s002_Replacementlbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761088Orig1s001s002Replacementltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761088Orig1s001s002_Replacementlbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761088Orig1s001s002Replacementltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-29
)
)