Application Sponsors
| ANDA 203170 | JIANGSU HENGRUI MED | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 40MG/ML | 0 | DOCETAXEL | DOCETAXEL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-02-15 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-09-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
CDER Filings
JIANGSU HENGRUI MED
cder:Array
(
[0] => Array
(
[ApplNo] => 203170
[companyName] => JIANGSU HENGRUI MED
[docInserts] => ["",""]
[products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/04\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/28\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/28\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-04
)
)