Application Sponsors
| ANDA 204193 | DR REDDYS LABS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
| 002 | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-11-05 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-01-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204193
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/05\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/01\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/03\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-04-01
)
)